chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was received from a healthcare professional on 09 August 2013. A 35-year old female patient whose medical history and concomitant medications were not reported had received an intramuscular first dose of ADACEL Vaccine (lot number U4646 AA) in her deltoid of the left arm on 07 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was unknown and the estimated date of delivery was reported as 25 September 2013. The patient had no healthy problem during pregnancy and had no specific risk factors. No laboratory details were provided. At the time of this report the patient did not experience any adverse event. List of documents held by sender were none.
10 days after vaccines, hives began (head to toe) with no fever, all over edema.
will call back to provide /account number to process credit / Credit pending; vaccine was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 3rd May 2021) and (batch number 23YL4, expiry date 4th April 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2021, the patient received Pediarix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 18th August 2021, the patient started Pediarix Pre-Filled Syringe Device. On 18th August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the expired vaccine used and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received pediarix in the left arm. The reporter stated that, she opened a box of Pedarix to give a dose, checked the expiration date on the box (lot 23YL4 exp 4/4/2022), pulled out the pediarix and administered the dose to the patient. After administration the reporter went to enter the lot and expiration date in the computer system and it did not allow her to do so because the vaccine was expired. The reporter checked the actual syringe and the expiration date said 3rd May 2021, lot MG92G instead of matching the boxes expiration date of 4th April 2022. The reporter stated that, the patient had not shown any symptoms currently from receiving the expired vaccine.  The reporter stated that, the syringes were usually stored in the original box until use and there was no evidence of tampering upon receipt. The reporter stated the last two lots ordered prior to this box were F4H92 and AZ472. Customer would be returning the box, 3 in date unused syringes left in the box, and the expired syringe. Glaxosmithkline to credit Customer for 4 doses of Pediarix to customers account. Customer would call back to provide wholesaler information and account number to process credit. Credit pending. The reporter consented to follow up.
At 11:00 PM awoke with severe full body chills and subjective fever that lasted about an hour. Woke again at 1:30 AM drenched in sweat with pounding frontal headache and eye aches, got up to use restroom and had vasovagal syncope while standing in front of the toilet.
PATIENT STARTED VOMITING WITHIN 10 MINUTES OF GETTING HIS 2ND PFIZER SHOT
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a improperly stored doses of GARDASIL 9 (lot# not reported). This is one of several reports received from the same source. Additional information has been requested.
Headache, chills, body aches, low grade fever. Increase water intake, ibuprofen, bed rest
I had covid before, when I got the shot I had fever, chills, headache and muscle soreness when I had both shots for 2 days. I started to break out in random rashes since May. Which we still don't know what the cause is. Eosinophilia Cellulitis closes thing they think I might have and I started having reaction to all kinds of things now. I have had over a  100 of these red spots all over my body they hurt to touch, they don't itch. They are generally the size of dime or a quarter. They don't know if maybe I'm having auto immune response.
patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 10-Sep-2021 and booster dose on 30-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Vaccines were thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as applicable  on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours No patients have reported any adverse events to date. No treatment medication information was given.
Information has been received from a physician concerning a 14 year old female who, on an unspecified date, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The physician reported that the patient "came in this week"  (approximately 10-MAR-2008), and stated that she had developed a "measles-like rash" at an unspecified point after being vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Unspecified laboratory tests were performed, results reported. It was unknown if the patient recovered. Additional information has been requested.
Patient received his two vaccines, 1 TDAP (ADACEL) and Menactra (MCV4P) on 5-14-2021. This was on a Friday after school. He had just tested NEGATIVE for glucose and ketones minutes PRIOR to the 2 vaccines.  The next day walking around the house asking us to feel his pulse under his chin and what a heart attack feels like. 16 days from shots he was throwing up, tired, etc.  43 days from shots he was in DKA in an ambulance with a 12.4 A1C.  Spent 3 days in hospital.  Diagnosed a Type 1 Diabetic.
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male 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 27Apr2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 at 18:30, after receiving the second dose, the patient experienced urinary tract infection (UTI) and had symptoms of some blood mixed urine. It was reported that the patient called nurse advisory and scheduled an appointment with the doctor. On an unknown date in 2021, the patient underwent urine test with the sample taken in the afternoon and no trace was found with any blood or bacteria. The patient was asked to give fresh sample taken in the morning. On an unknown date in 2021, the patient underwent urine test that showed traces of blood plus some bacteria. The event of urinary tract infection was confirmed. After the duration of 7 days, the urinary tract infection was clean. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with antibiotics prescribed by the doctor. The clinical outcome of the event urinary tract infection was resolved on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At 4:45 in the morning , A very sharp pain in the stomach woke me up , it was very quick maybe 5 seconds. I realized at that moment that my left arm was very painful like the feeling of getting 2 tetanus shot at the same time . I usually have a very high threshold on pain Right after that I experienced flu kind of side effects , aches , light fever and chills, shortness of breath light headaches and some nausea,
>103 Fever for four days; respiratory problems; large red inflamed at injection site,Arm measured 3-4 inches larger in circumference; burning; felt like covid again; Felt like he might die; Depression; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (>103 Fever for four days), RESPIRATORY DISORDER (respiratory problems), VACCINATION SITE INFLAMMATION (large red inflamed at injection site,Arm measured 3-4 inches larger in circumference), BURNING SENSATION (burning) and COVID-19 (felt like covid again) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), POTASSIUM, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MINOXIDIL, APIXABAN (ELIQUIS), ENALAPRIL MALEATE (VASOTEC [ENALAPRIL MALEATE]), aspirin low dose, LANSOPRAZOLE (PREVACID), METOPROLOL TARTRATE (LOPRESSOR), TORSEMIDE, HYDROCHLOROTHIAZIDE and ALLOPURINOL for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (>103 Fever for four days), RESPIRATORY DISORDER (respiratory problems), VACCINATION SITE INFLAMMATION (large red inflamed at injection site,Arm measured 3-4 inches larger in circumference), BURNING SENSATION (burning), COVID-19 (felt like covid again), FEELING ABNORMAL (Felt like he might die) and DEPRESSION (Depression). At the time of the report, PYREXIA (>103 Fever for four days), RESPIRATORY DISORDER (respiratory problems), VACCINATION SITE INFLAMMATION (large red inflamed at injection site,Arm measured 3-4 inches larger in circumference), BURNING SENSATION (burning), COVID-19 (felt like covid again), FEELING ABNORMAL (Felt like he might die) and DEPRESSION (Depression) outcome was unknown.        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.
Pt presented to the ED on 6/5/2022 with a rash that began the day she received her 4th Pfizer COVID vaccine.  diffuse rash.  The rash started Friday night after her 4th covid vaccination earlier that day.  The rash started in her groin b/l and has since moved up her abdomen and is on  her back as well. The rash is slightly irritating, currently 2/10. Otherwise, no  fevers, chills. She has not had prior reaction to covid vaccinations. No recent  medication changes.  Dermatology evaluated patient and  also felt urticarial and likely related to covid vaccination given timeline.  >>>PLAN: -Increase home cetirizine to BID until rash is resolving -Use home triamcinolone ointment for bothersome areas -Outpatient derm follow up (to be scheduled
Information has been received from a medical assistant concerning an adult female (age unknown) who was vaccinated on an unspecified date with Pneumovax 23 (Lot # 651401/0619F).  Subsequently the patient experienced swelling of the arm which was vaccinated.  At the time of this report, the patient was recovering.  The physician requested a lot check of Pneumovax 23 (Lot # 651401/0619F).  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Generalized non-febrile convulsion for less than 15 min with post ictal phase  11/10/09 Medical records received for DOS 10/29/09.  Final DX: New onset seizure.  ED visit. One day post vaccine. Isolated seizure. Total body shaking. LOC. Groggy vomited after. Labs WNL, CT showed sinusitis, prob viral. D/C to home. Follow-up with PMD.  11/18/09 Medical records received for DOS 10/28/08 and 10/30/09.   10/28/08 ED visit for fall w/head injury and bruise to forehead when 10 months old.  D/C to home stable. 10/30/09  follow-up visit s/p seizure. Acting very normal. No further seizures. EEG to be scheduled.
4 to 5 days after the vaccine, 05/30/2021, I felt a sore throat coming on, and drainage in the back of my throat. Sore throat was the worst I ever had.  A day or 2 later, I had chills in the evening, before bed. Not feeling good, a lot of gunk, mucous stuff, tired, little bit of headache, diarrhea.  These symptoms lasted for a number of days. By the 06/04/2021,I scheduled a COVID rapid test I was still feeling miserable. On 06/05/2021 - I went to see my doctor.  I was given a  strep test and rapid test-negative.  I was concerned about the mucous,  that it was becoming an infection. Diagnosed with viral cold. Prescribed  Mucinex and Flonase , Excedrin and drinking herbal tea and lot of rest. I still had drainage and cough for the whole month of June. Normally when I get sick I get better by a week. It was unusual that the sickness held on for as long as it did.( Vitamin D level was 61 taken recently. which is good. )
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had pain in arm. Consented to follow up. For tolerances of 2nd dose, refer case US2020167499, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167499:same patient
Delayed second dose / has been over a year since the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year before reporting).   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 information was provided 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 reporter inquired about a delayed second dose of Shingrix. It had been over a year since the first dose, reporter wanted to know should the series be continued or restarted. The reporter consented to follow up. Discrepancy: The patient's date of birth was not captured as it was future date.
10/9/13: 11 am chills, body aches HA/backache, arm pain, took ADVIL Q4 Hrs. 10/10/13: Skipped work, could not lift arm. 5 pm arm was very red, warm, has swelling about 3-4 inches. 10/11/13: visited Dr. got SEPTRA DS BID x 10 days. 10/12/3 fever at 10 PM. 10/13/13: Starting feeling better AM.
pt recvd vax; pt had widespread  morbiliform rash; pt exp cough, conjunctivitis; pt looked like he has mild measles;
feeling short winded; skin sensitivity/Overall sensitivity on skin, to cold, hot, wind, clothing, water; pain; dizziness; Skin is just hot; Been in bed all morning; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.  A 51-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiration date: not reported) via an unspecified route of administration, administered in the left arm at Pharmacy on 09Aug2021 at 11:00 (age at the time of vaccination was 51-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180, Expiration date: not reported), via an unspecified route of administration in the left arm on 19Jul2021 at (age at the time of vaccination was 51-year-old) as dose 1, single for COVID-19 immunization. On 09Aug2021, patient experienced feeling short winded, skin sensitivity/overall sensitivity on skin, to cold, hot, wind, clothing, water, pain, dizziness, skin is just hot and been in bed all morning. No additional vaccines administered on same date of the Pfizer Suspect and no prior vaccinations received (within 4 weeks). The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
10 minutes after shot I felt dizzy. The next day I was exhausted and slept all day. The next day I started having intermittent heart palpiations. I still have this throughout the day. I am still having them this morning.
face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021.   Information about lot/batch number has been requested.
Muscle pain and spasms in left shoulder, thigh, knee and calf, symptoms started shortly after vaccination (2nd dose) and have been ongoing since then
Fever, body aches,  headache, chills.  Took Tylenol for aches and fever. Symptoms continue at this time.
CLIENT RECEIVED (PEDS) PEDIATRIC PFIZER FORULATION OF 0.2ML AT 12YO. CLIENT SHOULD'VE RECEIVED GRAY-CAP FORMULATION OF 0.3ML DUE TO AGE.
UrticariaPriritus Rash at vaccine site (Lef deltoid) @ 11 Cm X 3.5 cm  Narrative:
Within 12 hrs localized redness, swelling, pain  within 48 hrs pain decreased arm to hand + numbness + tingling redness + swelling improved in 5-6 days, pain + numb/tingling persisting to date.  Will drop things from her hand
Site: Pain at Injection Site-Medium, Additional Details: When administering dose the vanishpoint syringe clicked and it appears the needle shot backwards in barrel in the middle of the shot instead of the end resulting in vaccine spurting out. I removed the barrel for destruction. I drew up another dose and was able to administer this successfully. Patient did report pain afterwards to which I gave him an ice pack but he returned a week later saying pain had improved 40%.