chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/17 pt began having fevers which continued for 2 weeks with sweating and chills. Patient diagnosed with MSSA bacteremia and later found to have a large left hemipelvic abscess. 03/12/07-records received from facility for DOS 12/8-12/20/16-DC DX: Methicillin sensitive staphylococcus aureus bacteremia. Multiloculated left hemi pelvic abscess. Left sacroiliac septic arthritis and extension into spinal canal. Osteomyelitis. Sustained a laceration on his left shin from a desk on 11/13/06. Shortly after, he began to experience mild left lumbar pain that was attributed to muscle strain from basketball practice. Received vaccines on 11/16/06. Developed fever which persisted and pain progressed to include right shoulder and migrated to his left. REceived vaccines in right and left deltoid. Left elbow hot and myalgias grew to encompass his entire body, fevers contined for 2 weeks with maximum temperature 102 at home along with sweating and chills. Nausea, vomiting and diarrhea for 1 week. Postiive localized left groin pain time 1. Lost 23 pounds.
Fevers, can't move arm due to pain, nausea/vomiting, dizzy
Pt vaccinated with Recombivax HB developed diarrhea was hospitalized. Stool culture revealed salmonellosis. Additional details have been requested.
Woke up itching my lower left leg and by morning had a rash on both legs, upper thighs, inside of upper arms, and lower arms, a few days later also on front shoulder area on both sides, which is still not completely gone. Red bumps appeared in those areas as well. I treated the areas with calamine lotion and cortisone cream as needed, since it looked like an allergic reaction.
Developed shingles on 06/12/21. Received second Phizer vaccine on 05/15/21
Loss of taste that evening only, some dizziness at time of vaccination - fatigue, muscle aches, nausea and declined in appetite. Symptoms have cont as of time of generating this report 12/29/2020  but has lessened in severity each day.
Sore left injection site arm after second dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after second dose of Moderna Covid-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045821A and 031821A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after second dose of Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after second dose of Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medications were reported   This case was linked to MOD-2021-386038 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up appended-HCP details added
Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old female patient who received a single dose of 0.25 ml vaccine FLUZONE (lot UI998AD, expiry date 30-Jun-2019) via unknown route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PARACETAMOL PEDIARIX; PREVNAR 13; PEDVAXHIB; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). It was an actual medication error due to inappropriate age at vaccine administration. There were no side effects at the time of this report. 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.
Burnt taste and smell; Burnt taste and smell; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Mar2021 at 15:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 00:00, the patient experienced burnt taste and smell to everything. The clinical outcome of the events burnt taste and smell to everything was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Upon assessment resident noted to have increased respirations, lungs CTA. Resident c/o increased fatigue and muscle aches. VS 202/180, 118, 22, 97.1, 96%.
On 10/19/2012 claimant entered pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care at hospital. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protect the elbow. Follow up care indicated a rise in blood pressure, Laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 104 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Since injection have had continuous pain/aching/soreness in (L) arm from shoulder to elbow. (During the injection in (L) deltoid - felt burning down to elbow and some tingling in hand then and still intermittent). Decreased range of motion in some positions due to pain.
On day 3 post immunization administration itching and rash developed to the occipital head, posterior neck, left lower abdomen and right lower abdomen.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Staph infection on the legs; Hot to the touch rash on both legs; Fluid leaking out of broken skin on legs; Broken skin on the legs; Legs swelled up; Rash on both legs, Arms and Upper Body; A spontaneous report was received from a 68 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced staphylococcal infection, peripheral swelling, hot feeling in feet, skin oozing, skin breakdown, rash on legs, arms and upper body.  The patient's medical history included swelling of legs, weak immune system and use of steroids medication stopped prior to vaccination. No concomitant medications were reported.   On 24-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 011A21A) intramuscularly on right arm for prophylaxis of COVID-19 infection.  On 27-Feb-2021,the patient's legs swelled up like never before, had a rash on both legs that was hot to the touch, the skin broke on the legs, and fluid leaked out of broken skin. After the doctor's visit and treatment, the rash moved to arms and upper body. No laboratory data was provided. Treatment included diphenhydramine and treatment for staph infection.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event staphylococcal infection was considered as resolved on an unknown date in MAR 2021. The outcomes of the events peripheral swelling, hot feeling in feet, skin oozing, and skin breakdown were considered as resolved on 10 Mar 2021. The outcome of the event rash was considered as recovering at the time of the report.; Reporter'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.
She was sluggish this morning, barely interested in Christmas presents.  Also, she was complaining of pain and "heat" in her left upper arm where she was given her first HPV vaccination (same date/time as Flumist).  Her appetite has been miniscule- not even Holiday dinner. She slept from 1pm to 7pm then developed a fever of 101.2 at last check at 11pm on 12/25/14.  She is also extremely congested and she says her brain hurts.  I've been treating her with Motrin for discomfort during the day so we are continuing that for fever control along with Sudafed for congestion.
The patient reported that her arm was red, itchy and swollen about one week after her first vaccine.  She was also fatigued.  She said that the reaction resolved in a couple days.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
received 1st dose of Shingrix / 03/10/2020/ did not receive 2nd shot yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th March 2020).   On an unknown date, the patient received 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were provided for 1st dose of Shingrix. The reporter consented to follow-up. No further information was reported.
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 22-FEB-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 22-FEB-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 025L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 9:59 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 22-FEB-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On 22-Feb-2022 at 9:59 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 22-FEB-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vaccines were initially placed in the refrigerator on 19-Jan-2022 No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up information received included no new information.
lips numb/tingly/sl swelling some increase in  dyspnea diaphoresis rask across upper lip and abdomen
9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. BP 151/86 HR 75 RR14 Sat 98% 0.9 % NSS to keep vein open Benadryl 50 mg IV one dose stat
C/o rash and itchiness starting evening after injection, and up to 3 days after. No tx sought
ADACEL was given to the patient at age 11 and then ADACEL was given to the patient again at 15 years of age/no AE; Initial information was received on 23-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 15-year-old female patient was received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6855AA, expiry date-29-Nov-2022) via an intramuscular route in the left arm for prophylactic vaccination 16-Apr-2021 at the age of 11 years and then again at 15 years of age (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
5 hours after the shot I began feeling like I had a sore throat and was hoarse. Shortly after that I started feeling very tired and weak. Went to bed early but then started having a fever and chills. Could not get warm or cool off. Both of these conditions went back and forth. Had a headache. My fingers and toes were feeling numb. Was awake most of the night feeling like this.  Next day was very tired and weak.
Body pain Swollen lymph nodes in jaws and armpit  swelling of tongue and throat runny noise
Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 21Feb2021 14:00 (at the age of 58-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since the vaccination. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications received within 2 weeks of vaccination. On 10Mar2021 at 11:30 AM, the patient experienced massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung). The patient was hospitalized for the events for 4 days. The events were also considered as life-threatening. Therapeutic measures were taken as a result of massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung) which included intravenous anticoagulants and injected anticoagulant. The patient was recovering from the events.  Information about the lot/batch number has been requested.
Administered past the 30 day refrigeration time; Fever; Achiness; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time), PYREXIA (Fever) and MYALGIA (Achiness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025L20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppressant drug therapy (immunosuppressant medication).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Achiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PYREXIA (Fever) and MYALGIA (Achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. She received the 3rd dose because she is on immunosuppressant medication   This case was linked to MOD-2021-314740, MOD-2021-314678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up information received and added Reporter and Information added for dose 1 and dose 2.
Received 3rd dose Pfizer vaccine 10/11. New onset dizziness 10/16. No fever, ear pain, tinnitus, orthostasis, palpitations. Worse with head movement. Positive Dix Hallpike during office visit.
Started experiencing chest tightness and pressure on 11/15/21 and was instructed to go to the ED.  She was discharged w/ instructions to follow up w/ her endocrinologist.  Dr. restarted her on methimazole 5 mg QD but increased her dose to BID when pt continued to experience weight loss, palpitations and heat intolerance.  Her symptoms improved w/ the increased dose.  She was prescribed atenolol but did not start it right away.  As of her last endo visit the plan is to monitor thyroid function test every 4 to 8 weeks based on her symptoms and adjust methimazole as needed.    Start atenolol with palpitation recurrence.  Discussed radioactive iodine treatment and surgery given her fluctuating thyroid levels, she prefers to stay on medications at this point.  Follow up endo appt in 6 months.
First 2 days - fatigue, slight head ache,  slight pain at injection site.  All that went away, and I though no more of it until exactly 8 days after the injection, I developed a intense itch at the injection site as well as a red rash and it is painful. Google tells me this being called "Covid Arm" and is nothing to worry about.  So, I'm not worrying about it, but I felt it was interesting enough to report.