chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 04/16/2003 from a 32 year old female consumer with an autoimmune disorder who on approximately 04/02/2003, two weeks ago, was vaccinated SC with a 0.5ml dose of pneumococcal vaccine 23 polyvalent.  There was no concomitant medication.  On approximately 04/02/2003, "soon after" the vaccination, the patient developed soreness and swelling in her left shoulder, which soon went away.  On approximately 04/09/2003, one week ago, the patient developed a swollen and sore lymph node in her armpit.  As of the report on 04/16/2003, the patient did not recover from the swollen and sore lymph node in her armpit.  Unspecified medical attention was sought.  Additional information has been requested.
TOOK MACROBID WHILE TAKING VIVOTIF; URINARY TRACT INFECTION; This spontaneous case (PVX2019-876) was received from a nurse on 15-Apr-2019. It describes a 53-year-old adult female consumer who was diagnosed with urinary tract infection (UTI), after the administration of oral Vivotif (one capsule every other day; lot number: 3003215) for typhoid prophylaxis. She also "took Macrobid while taking Vivotif" for the treatment of UTI.   Case report: The consumer took 3 doses of Vivotif on 10-Apr-2019, 12-Apr-2019, and 14-Apr-2019 respectively. On 14-Apr-2019, she was diagnosed with UTI for which she started Macrobid (nitrofurantoin; 100 mg; twice a day) on 15-Apr-2019.   The consumer had no medical history.  Action taken with Vivotif and Macrobid with respect to the event urinary tract infection was unknown while with respect to the event "took Macrobid while taking Vivotif" was not applicable.  The clinical outcome of the event urinary tract infection and "took Macrobid while taking Vivotif" was unknown   The reporter considered the event urinary tract infection unrelated to vaccine.  Company's Comment: In this case, a 53-year-old adult female consumer developed urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, a 53-year-old adult female consumer developed urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.
administered a dose of Shingrix that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 24th May 2022, the patient received Shingrix. On 24th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 50 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 1 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097903:Same Reporter, patient 2 US-GLAXOSMITHKLINE-US2022097904:Same Reporter, patient 3 US-GLAXOSMITHKLINE-US2022097905:Same Reporter, patient 4 US-GLAXOSMITHKLINE-US2022097908:Same Reporter, patient 5 US-GLAXOSMITHKLINE-US2022097904:Same Reporter
Inappropriate schedule of vaccine administered; Half of my stomach looked like it was sun burned. The area was red from under my right breast downto the bikini line with belly button being the dividing line; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 20:00, the patient had inappropriate schedule of vaccine administration. Approximately 8 hours post second dose, the patient was changing for bed and noticed that half of her stomach looked like it was sun burned, the area was red from under her right breast down to the bikini line with belly button being the dividing line. It was not hot to touch nor was it a rash. The patient would not have noticed it because it did not bother her except when she went to change her clothing it was visible. On 21Mar2021 (next morning), it was gone. The patient did not receive any treatment for the events half of my stomach looked like it was sun burned and the area was red from under my right breast down to the bikini line with belly button being the dividing line. The clinical outcomes of the events half of my stomach looked like it was sun burned and the area was red from under my right breast down to the bikini line with belly button being the dividing line were recovered on 21Mar2021 while that of inappropriate schedule of vaccine administered was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Slight pain in the arm/experienced slight pain in the vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight pain in the arm/experienced slight pain in the vaccinated arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cellulitis and Cancer.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Slight pain in the arm/experienced slight pain in the vaccinated arm). In February 2021, VACCINATION SITE PAIN (Slight pain in the arm/experienced slight pain in the vaccinated arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient is receiving cancer treatment currently. She is also receiving IV treatment for cellulitis. No treatment medications were reported.      This case was linked to MOD-2022-440018, MOD-2022-440019 (Patient Link).
I received a baseball size lump at injection site the next morning. It was painful. After a few days it went down and the rash spread all the way down my arm to my elbow. I had high fever first 24 hours of 101 and then low grade even today. The itch and pain has no travelled to my armpit and elbow. My lymph are also swollen in my armpit and chest.
expired dose given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information were provided.   This case was linked to MOD-2022-568302, MOD-2022-568301 (Patient Link).
Tendinitis or bursitis; Tendinitis or bursitis; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDONITIS (Tendinitis or bursitis) and BURSITIS (Tendinitis or bursitis) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced TENDONITIS (Tendinitis or bursitis) and BURSITIS (Tendinitis or bursitis). The patient was treated with IBUPROFEN for Tendinitis and Bursitis, at an unspecified dose and frequency and CORTICOSTEROID NOS for Tendinitis and Bursitis, at an unspecified dose and frequency. At the time of the report, TENDONITIS (Tendinitis or bursitis) and BURSITIS (Tendinitis or bursitis) had not 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.   The treatment medication included Ibuprofen and Cortical steroid.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a pharmacist referring to a 50 year old female patient with pertinent medical history of high blood pressure and high cholesterol. Information regarding drug allergies was unspecified by the reporter. On 04-JUN-2015 the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not reported). Concomitant therapies included simvastatin (manufacturer unknown) and lisinopril (manufacturer unknown). On 05-JUN-2015, the patient experienced a red, hard rash around the unspecified injection site area described as "it was about 3 inches across the injection area and it was getting larger". The patient sought medical attention by seeing the pharmacist on an unknown date. No lab diagnostics studies were performed and no treatment was given for the event. Outcome of the event was not recovered. Causality assessment was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Reddened raised area; hot to touch; painful at injection site, approximate size small orange by 11/7/10 with flu like symptoms x 2 days. Treated with ibuprofen q 4 h for 1 day.
3:35 PM Patient received Adult Td. 3:50 Patient experienced difficulty swallowing, cool clammy skin, pale, color around mouth and eyes. 3:55 Patient vomiting, chest clear, no wheeze. 4:03 PM Feeling better; color improved, vomiting eases, RR stable, continued no respiratory symptoms. 4:03 - 5:30 PM Monitored; patient stable, reading novel. Tolerated fluids well. Discharged to home in stable condition. Follow up with TC 5/5/05 9:30 AM No concerns; no symptoms, no sequelae
This spontaneous report was received from a registered nurse regarding a 4 months old female patient. Information on pertinent medical history and concomitant medications were not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot# R013570 with expiry date of 18-MAR-2021 for prophylaxis. No adverse effects were reported. Temperature: (-1.1 C) (Below 0.0 C). Time frame was 8 hours 10 minutes. There was no previous temperature excursion. The call was because of data logger. No product quality complaint (PQC) was present.  This case was related to MARSS# 1902USA011294 and 1811USA006589 (Same reporter link).
I got my second dose of the Covid vaccine on 5-16-21 and my right arm is still sore weeks after and it has gone away as of today 6-10-21. I can?t lift anything heavy with out it hurting.
In the last three weeks I had an unexplained rash on my left palm of my hand. It was not healing and cracking and peeling. I went to see a dermatologist. He said it was psoriasis. Which I?ve never had before. He prescribed a medication, and it is now resolved. I was pregnancy during 4th vaccination during pregnancy I did have Partial Placenta previa, it resolved. I had no other complications. My child?s estimated due date was 09/20/2022, I gave birth, 8 lbs. was the birth weight. After vaccination I had strong Flu like symptoms for one to two days.
Contracted Covid-19; Contracted Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had 2 primary doses of vaccines and 1 booster dose. Contracted COVID-19 and took Paxlovid then experienced viral rebound after Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200058403 same drug/ event, different patient;
Woke up with soreness to the injection site, with bad headache, nausea, joint pain (both wrists and knees), rash on forehead and fever; took acetaminophen for relief; noticed decrease in bowel movement for 2 days; noticed painful 1cm lump on R midclavicular area and fullness to soft tissue above R clavicle.
Pt recvd vax approx 4PM 19FEB92; about 7-8pm began crying & t100; 10-1030 pm acted like convulsing took to Er & temp was 105.5; 20FEB92 screaming >1 hrs & t101; seen by MD told allergic rxn to pertussis & only get ped DT in the future;
Extra dose administered; No Adverse Event; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2371879-1. The original narrative from the sender is the following:  PENTACEL and VAXELIS were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5- component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid [Vaxelis] were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jul-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, strength unknown (lot UJ621AAA and expiry date 20-Jan-2023) via intramuscular route in the right thigh and on same day the patient received a dose of suspect diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid not produced by Sanofi Pasteur (formulation, dose, strength ,lot number and expiry date not reported) via unknown route in unknown administration site both for immunization was administered at different sites on the same day, causing an extra dose to occur with no reported adverse event (extra dose administered). Action taken : not applicable. Outcome : Unknown. 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 guidelines. 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.
c/o anxiety and anxiousness.     He has history of anxiety.  BP was 139/92, HR 110.   Pt. refuse care and went home.
COUGH, SOB, MUSCLE/BODY ACHES, HEADACHE, FATIGUE, LOSS OF TASTE AND SMELL
12/13/2021 03:30PM chills pain pressure in chest then heart rate on watch and shortness of breath and chest pain lasted all night.  07:40 PM. taken the hospital, waited 3 hrs.  to triage and was in hospital for 12hrs.  Fever of .99 usually runs lower at 96, bad headaches, and pain in neck.  Chest X-ray, blood work panel for two pages and two EKG and COVID test.  Visual Observation and prescribed Tylenol for pain and told to follow-up with primary physician 3-5 days.
No adverse reaction reported; we are reporting an administration error.  The administering pharmacist gave the patient the pediatric dose of the Moderna covid vaccine instead of the new bivalent booster.  We contacted Moderna and they recommended we file this report.
bleeding from the underarm; muscle cramps; dizziness; headache; muscle pain; swelling in their armpit; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding from the underarm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bleeding from the underarm) (seriousness criterion medically significant), MUSCLE SPASMS (muscle cramps), DIZZINESS (dizziness), HEADACHE (headache), MYALGIA (muscle pain) and LYMPHADENOPATHY (swelling in their armpit). The patient was treated with NAPROXEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HAEMORRHAGE (bleeding from the underarm), MUSCLE SPASMS (muscle cramps), DIZZINESS (dizziness), HEADACHE (headache), MYALGIA (muscle pain) and LYMPHADENOPATHY (swelling in their armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Patient experienced headache, dizziness, muscle pain/cramps, swelling in their armpit, and bleeding from the underarm. Therefore, patient decided to switch it up for their second dose.  Company Comment: This is a spontaneous case concerning a 61-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Haemorrhage. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. Naproxen and Tylenol are used as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-413636 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 61-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Haemorrhage. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. Naproxen and Tylenol are used as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Rash, itching, red swollen blistered skin for 10 days  numbness at time of reporting 10 days Valtrex for one week
second dose administered two months after the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered two months after the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered two months after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered two months after the first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Patient states that after she received her H1N1 vaccine that later that night she felt "tired". She states that this also continued into the next day. She also complained of redness and itching at injection site, although she could not give this RN a specific onset of these symptoms.She just states that itching and redness began a "few days after the shot" although unable to give exact time/day. She also describes the feeling of her arm feeling "cold" that comes and goes and that radiates into her neck and hip on the left side. Patient also unable to give an exact day/time for the onset of this starting. Patient also reports concern that the nurse giving the vaccine dropped the syringe in the floor, changed out the needle and replaced with a clean,capped needle. Pt still complains of intermittent itching and the "cold" feeling. She also reports that this all could be related to a car accident where she was rear-ended on 10/28/09.
ABOUT 10 MINUTES AFTER RECEIVING THE SEASONAL FLU VACCINE, VICTIM NOTICED SHE WAS SLIGHTLY DIZZY AND THAT SHE HAD BITTEN HER TONGUE REPEATEDLY IN THE LAST FEW MINUTES, ALSO SHE HAD TINGLING ON HER ARM AND ON HER FACE. SHE SAT DOWN AND NURSES WERE CALLED. VITAL SIGNS AND O2 SATS WERE NORMAL BUT VICTIM STARTED SLURRING HER WORDS AND STATED HER TONGUE FELT LARGER AND HER THROAT FELT TIGHT. 50MG. IM BENADRYL WAS ADMINISTERED AT THAT POINT. AFTER 10-15 MINUTES VICTIMS SPEECH NO LONGER SLURRED AND SHE STATED RESOLUTION OF THROAT TIGHTENING, TONGUE VISIBLY SMALLER AND PER HER NOW NORMAL IN SIZE. VITAL SIGNS WERE NORMAL THROUGHOUT AS WELL AS O2 SATURATIONS. ADVISED TO SEE HER PCP AND REPORT THIS REACTION TO THE FLU SHOT. ON INTERVIEW THE FOLLOWING DAY, VICTIM STATED SHE HAD HAD NO OTHER SYMPTOMS OR RETURNING SYMPTOMS OVER THE 24 HOUR PERIOD.