chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when administering ADACEL to a patient a few drops leaked under and around the luer lock, therefore patient did not received entire 0.5mL dose, no AE; Few drops leaked out under the luer lock with no adverse event; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional (under the reference 00735729).  This case involved a 17 years old female patient who did not received the entire 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] due to the drops leaked out under the luer lock (underdose, syringe issue).  The patient's past 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) (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  On 23-Aug-2021, the patient received a second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, 0.5 ml once, lot U6984AA and expiration date: 18-Mar-2023) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to vaccine underdose (same day latency) and also a case of syringe leak (same day latency).  It was reported Call received from HCP reporting when administering ADACEL to a patient a few drops leaked under and around the luer lock, therefore patient did not received entire 0.5mL dose. Caller with question on whether dose needs repeating. Direct, Indirect from a distributor, neglected to ask; Number of units affected: 1. Is dose not used or not available: used. Whether product is available for return; Leaking (gather as much info as possible); Where is it leaking from? (use vial & syringe guides). Under the luer lock o When did the leakage occur? when administering; Quantity of the leak (e.g. only a few droplets or half the dose) a few drops; Diluent or vaccine leaking? vaccine; During withdrawal from vial? NA  (not applicable); Sanofi Pasteur prefilled syringe or your syringe? prefilled syringe; Was air injected into vial? NA; Was there a vacuum in the vial? NA; Was vial punctured multiple times? NA; Did the product spray out of the vial? NA; Any signs of damage or tampering with the vial, stopper, flip seal or carton? No; How often was vial punctured? NA.  At time of reporting, it was unknown whether the patient had any adverse event or not  and the outcome was unknown for the reported event.  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. 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.
On 11/30/99, the pt developed chickenpox. The pt sought unspecified medical attention. No further information is available.
Headache X 2 days, palpitations x 3 hours, fever x 1 day
Pregnant; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included GERD (worsened with pregnancy, no change with vaccine, improved after delivery) and Food poisoning (food poisioning with dehydration, electrolyte changes) from 01-Dec-2020 to 02-Dec-2020. Previously administered products included for Product used for unknown indication: Tdap on 10-Dec-2020. Past adverse reactions to the above products included Product used for unknown indication with Tdap. Concurrent medical conditions included Penicillin allergy, Drug allergy and Sulfonamide allergy (sulfa allergy). Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Acid reflux (esophageal), ONDANSETRON (ZOFRAN [ONDANSETRON]) and PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 28-Dec-2020 at 6:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-May-2020 and the estimated date of delivery was 25-Feb-2021. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The cesarean delivery occurred on 13-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3160 grams (6lbs 15oz) with an APGAR score of 8 and 8 at (1, 5 minutes). The outcome was reported as Term Birth w Complications. Non-reassuring fetal tracing due to nuchal cord. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Ultrasound scan: normal (normal) normal. On 26-Jun-2020, Pregnancy test: positive (Positive) positive. In December 2020, Glucose tolerance test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception was 06 Jun 2021. Number of fetus is one.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Pregnancy outcome form added; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
redness around the injection site; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Regulatory Authority (Reference number- 00636207) and transmitted to Sanofi on 10-Jun-2021.  This case involves a patient (unknown demographics) who had redness around the injection site (vaccination site erythema) while receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious redness around the injection site (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  This event affected 3 patients.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
I received the vaccine at 5:00pm on Feb 4. In the middle of the night around 3:00am I was woken up by intense lower back pain. Over the course of the next 48 hours the pain increased with terrible spasms where I was rendered incapacitated. In the days following, continuing to today, (February 12th) , my back remains in pain, but to a lesser degree, allowing me to be functional while consistently uncomfortable. As I mentioned before, in 2017 I had the LAP flap reconstructive surgery. The area of my pain is around the incisional site of my surgery.  The pain was similar to how I felt post surgery. While I accept that this could be a strange coincidence, it is important to note, that since recovering from my surgery, I have not suffered any meaningful back pain.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Syncope-Medium, Additional Details: Patient was in the waiting area after recieving vaccine where he fainted and fell out of his chair. His female friend asissted him and reached out to us. He regained consiousness and was able to speak to us clearly. There was a small cut above the left eye. He expressed that he has a fear of needles and this has happened before to him as well. He had no symptoms of an allergic reaction, no headache or visual distrubances. We monitored him for 30 minutes and did not feel the need to call 911.
she ran a very high fever; This is a spontaneous report from a contactable consumer, the patient.  A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was getting her covid shot tomorrow and after the last dose she ran a very high fever. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had blood work done in March of 2022, the results came back as very high liver enzymes. I am now seeing a specialist to find out why my liver is damaged. I don't drink often, and do not take any medications to cause it. The specialist does not know why. He ordered a liver biopsy on 04/20/2022. I will be doing more blood work in 8 weeks. I was told not to drink any alcohol at all and lose some weight to see if this helps. I am not a heavy drinker, and not sure why this is happening.
I tested positive for COVID-19 on 10/25/22. I had a sore throat, headache, fever, and body aches. I took an at home test and it was positive. I called the doctor, and they prescribed five days' worth of PAXLOVID. I am feeling much better now since I started taking PAXLOVID. I still have a raspy voice, but other than that I feel good.
Patient had redness and swelling about 2 inches below the injection site, tenderness, no anaphylactic reaction. Area was treated with ice, Benadryl, OTC allergy medication and Tylenol as needed for discomfort. Symptoms resolved by 10/8/18. Upon inspection it appears shot may have been given to low in the deltoid resulting in SQ injection. Patient has gotten the flu shot over the past 7 years with no issues.
Pain in chest and back began on Wednesday 4/14.  What started out feeling like an uncomfortable pulled muscle in my back/chest area on Wednesday escalated rapidly to very sharp stabbing pains in my chest and back by Thursday afternoon 4/15.  After discussing my symptoms with the office of my PCP Thursday afternoon, I was told to go to the Emergency Room for evaluation.  I checked into the ER at approx 6pm that Thursday evening on 4/15.  While there I underwent a blood test, EKG and a chest Xray.  Upon evaluating the results of each test the Dr on assignment stated that there were no problems with major organs but could not diagnose.    Small red marks began developing on the right side of my chest that same day and progressively expanded in quantity across the right side of my chest and back.  A follow-up visit with my PCP was completed on Tuesday 4/20 and the diagnosis of Shingles was confirmed.  Pain has not subsided and has only gotten worse as of 4/21.  Prescription treatments began the evening of 4/20.
right side chest pain and mild heart failure with bilateral pleural effusion and increased SOB- seen in hospital ER twice in 24 hours
Developed temp 103 (R) X 3 days, hyperactive, personality change, miserable, laying on floor screaming, arching back & crying. Could sleep no longer than 1 hr at a time during 3 days. Anorexic.
11/13/22 Flu-like symptoms, for aprox 48 hrs; 11/14/22 home-test pos for Covid; 11/20/22 home-test again = Covid neg; 4/26/23 told by dentist that x-rays from 4/12/23 show dental resorption in molar; tooth extracted, rec'd Rx for 800mg ibuprofin as needed and 7-day course 500mg amoxicillin; 5/4/23 itchy rash 80% of body, assumed by urgent care Dr to be allergic reaction to amoxicillan; began 5-day course of 40mg prednisone plus antihistamines as needed; rash mostly resolved by 5/9/23; Rec'd unspecified flu vaccine at same time as 11/8 Covid vaccine. Had not previously been allergic to any medications. Also Janssen 6/22/21, Moderna 10/24/21, Pfizer 5/5/22,
Pain in left armpit; Tender to touch; Body aches; Tiredness; Headache; Muscle pain; This is a spontaneous report from a Non-contactable Other Health Professional (Patient reported for herself). A 23-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 06Feb2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Jan2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 06Feb2021 at 20:00, the patient experienced pain in left armpit, tender to touch, body aches, tiredness, headache, muscle pain. Adverse events resulted in was reported as none. No treatment was received for the events. The outcome of the events was reported as resolving.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Patient 1st covid vaccine on 11/19/21 afternoon, also had wellness no other vaccines but did have fasting labs that morning. Saturday morning woke up fine just sore rt arm. Then later that morning was sitting on couch, got up to go into room, states as she was walking in the hall for few seconds saw all black & felt she was going to fall. It was so random & quick. States she did not feel dizzy, and that ?all sudden all went black? States this feeling didn?t come back rest of day.  Then Sunday morning, had same episode. She was already awake, was sitting on bed, got up to go into living room, started walking, and again just randomly, states all went black and felt she was going to fall. Denies feeling dizzy, confused, no nausea.  Patient was worked herself up right before labs on Friday. She was very scared, and anxious, and was fasting.  These symptoms only happened 2 days after, has not had more symptoms other than sore injection site.
Second part. Took  Advil 400 mg and was fine after vaccine. Had at fib at about 10:45 pm and woke up with at fib at 2 am 1/24/21.
Initial report received from healthcare professional on 17 April 2014. A patient, whose gender, date of birth, age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, route and anatomical site of administration were not reported) on an unspecified date of 2011. It was reported that on an unspecified date, after receiving FLUZONE HD, the patient experienced rash on both arms and trunk. The corrective treatments and laboratory investigations were not reported. The patient was recovered within one week on an unspecified date. Documents held by sender: none.
Arm swelled to double size for 3 to 4 weeks. It was red and hot and you could not touch it.
Fever began 6 days following vaccine and progressed to shortness of breath by day 10. Tested positive for COVID on day 11, admitted to ICU on day 12, intubated and placed on ventilator on day 15, and died on day 57.
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 11/17/21 and the second dose of Moderna COVID-19 Vaccine on 12/8/21 which is earlier than 28 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Received both doses / Herpes zoster outbreaks/  suspected vaccination failure; Herpes zoster outbreaks on her buttocks; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure and herpes zoster were recovering/resolving.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received both doses of what she believed was Shingrix, four years before time of reporting. She could not remember the date.  She stated that she started having herpes zoster outbreaks on her buttocks at that time.  The patient did not have them as frequently and that she had not had an outbreak for two weeks.  She wanted to know a remedy for it. She stated she would talk with her doctor. The reporter did not consent to follow up. No information given. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
a patient was administered an  IPOL two days after it was expired/ No AE; Initial information received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from a other health care professional via physician via phone via Global Medical Information (GMI) number: 00696908.  This case involves a 15 years old male patient who was administered an IPV (VERO) [IPOL] two days after it was expired (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination and METHYLPREDNISOLONE (PD).  On 19-Jul-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) lot R1D972M, expiry date: 17-Jul-2021, Frequency: once, strength: standard, via intramuscular route in the deltoid (unsure which side) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine administered (latency: same day).  It was reported "Caller administered IPOL two days after it expired, she wants to know what she should do now, is the dose valid, is there any interaction with using an expired vaccine, when should she notify the patient. Caller states the patient did not report any adverse events."  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.
Moderna COVID-19 Vaccine  Severe dizziness for 10 seconds. Dizziness subsided on its own so I did not call my physician. No additional episodes experienced.
ARM ITCHED; INJECTION SITE SLIGHTLY SORE/IT WAS ARM TO TOUCH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient experienced arm itched and injection site slightly sore/it was arm to touch when treated with influenza vaccine for prophylactic vaccination. 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 covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced arm itched, and injection site slightly sore/it was arm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site slightly sore/it was arm to touch and arm itched was not reported. This report was non-serious.
pt reports she wound up in hospital with cellulitis.  started as plum sized lump and continued down her arm as larger area.  She still feels scar tissue under injection site
Around 3pm I began feeling so weak and sleepy I was struggling to keep my eyes open while typing emails for work. By 8pm I had a mild fever and was freezing. The next day the fever persisted and I have aches and chills. I slept most the day. The fever did not break till the next morning. I was only taking acetaminophen for the fever and pain.
My left arm still aches and seems to have become weaker, although it has been a month since the 2nd shot.; My left arm still aches and seems to have become weaker, although it has been a month since the 2nd shot.; This is a spontaneous report received from a contactable consumer (Patient). An elderly male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL1284), via an unspecified route of administration administered on Arm Left on 02Feb2021 10:45 at single dose for covid-19 immunisation. Medical history was reported as none and had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications in two weeks included finasteride, meloxicam, and latanoprost. The Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL1284) administered on Arm Left on 13Jan2021 07:45 AM. On 03Feb2021, the patient experienced left arm still aches and seems to have become weaker, although it has been a month since the 2nd shot. No treatment was received. The outcome was not recovered.  No follow-up attempts are possible. No further information is expected.