chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JAN-2016, the patient was vaccinated with first dose of GARDASIL 9. On 01-MAR-2016, patient received second dose of GARDASIL 9 (dose, frequency, route of administration and lot number were unspecified for both dosage regimens). No adverse effect reported. The outcome of the events was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient states she had a mouth full of canker sores that started a few days after getting the vaccine.
Almost three weeks after the shot I had a half dollar size red spot on the arm. It is now going on 5 days and it is not as red, like it is disappearing.
Pneu L deltoid. Approx 8:20 am after giving Flu shot in R deltoid he said he felt dizzy. He slid off chair onto floor. It did not appear to me that he hit his head. Came to immediately stated he did not eat or drink today. 1st BP 140/90 (5min)118/80 (15min)110/78 P 58. Tel. call x 2 to this pt. no response.
From the day after the shot and ongoing: Fatigue, joint pain, joint swelling, neuropathy (tingling/numbness) on the bottoms of both feet, brain fog
24 hours after receiving injections the patient had a red rash, a fever less than 100F. The rash is generalized, erythematous, and maculopapular eruptions.
Arthralgia FATIGUE, CHILLS, PAIN/SWELLING INJ SITE  Narrative:
This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot# M036296 with expiration date 14-NOV-2017; and lot# M037013 with expiration date 22-NOV-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 15 and 46 Fahrenheit degrees (also reported as "23.9 F") for a time frame of 7 hours and between 6 and 14 Fahrenheit degrees for a time frame of 8 hours and 30 minutes; digital data logger was involved. There were not previous temperature excursion for the vaccine. No adverse effects were reported. Additionally, it was reported that the sterile diluent (unspecified) used to reconstitute the administered vaccine did not undergo a temperature excursion (Lot # M015992 with expiration date 26-NOV-2018; Lot # L037795 with expiration date 04-MAY-2018; Lot # L019306 with expiration date 04-MAR-2018; Lot # L006552 with expiration date 12-NOV-2017; Lot # M001834 with expiration date 08-MAR-2018; Lot # M022946 with expiration date 17-DEC-2018; Lot # M024781 with expiration date 21-FEB-2019). There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA010175: US-009507513-1704USA001189.
Left side numb, Equilibrium off, Shortness of breath that comes and goes, Cant walk correctly, "discombobulated"  pt believes they had a worsening of their MS
Sudden onset of fever of 102 degrees F, muscle pain, dizziness, shivering, redness of arm and firmness in IMZ area on arm, fever went down approx 6 hours later.
Upper L arm with 12x12 cm area induration, warm, erythema.  Tx: clindamycin.
Intense body aches; Muscle soreness at injection site; Fever; Chills; Nausea; Excessive Bowel movements; Tiredness; Skin Sensitivity all over body; Right ear ringing; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 17:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included oral lichen planus. The patient took unspecified compounded mouthwash but never ingested as a concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 08:00 AM, the patient experienced intense body aches, muscle soreness at injection site, fever, chills, nausea, excessive bowel movements (6 in one day), tiredness, skin sensitivity all over body and right ear ringing when the pain was really bad. Therapeutic measures were taken for the reported events included two Tylenol extra strength capsules, 500 mg each. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent lab test and procedures which included nasal swab test and the result was negative. The clinical outcome of the events intense body aches, muscle soreness at injection site, fever, chills, nausea, excessive bowel movements, tiredness, skin sensitivity all over body and right ear ringing was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Experienced  intense hives peppered over multiple areas of body.  Intense itchy and spread of hives required seeking and getting medical treatment.  Steroid  injection given at walk-in care facility followed with a prescription for oral steroids along with taking Benadryl and eventually Loratadine.  Had to take tylenol and ibuprofen due to side effects from steroids.  Immediately started experiencing headaches with steroids while receiving steroids by injection and orally.  Light headedness, dizziness, headaches and nausea were all side effects of the steroids. The Physician Assistant that saw patient was extremely concerned for anaphylactic shock and questioned multiple times and caused should I experience any shortness of breath, any numbness or tingling in the mouth, lips or airways to seek immediate medical attention at the Emergency Department of the local hospital.   I was until 9/9 before I felt as though all the side effects of the vaccine and the adverse reaction appear to have gone away for the time being.
ACUTE PULMONARY EMBOLISM  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN  ACUTE HYPOXEMIC RESPIRATORY FAILURE         HYPOXIA 08/26/22 patient admitted to the hospital for same sypmtoms
Modern a COVID-19 Vaccine EUA Pink circle at shot location, seems to be itchy , is not warm to caregivers touch,  person does not have a fever Warm cloth, cream on arm lesson the itchy feelings in other parts of her arm due to normal dry skin Calling her primary care doctor  01/25/2021
pt recv vax in 1995 & devel chickenpox; No further details were provided;
Severe adverse reaction.  Unable to walk 1-2 days due to arthritic conditions in joints.  High fever over 100 for 3 days, body aches and muscle ache, suffer from arthofibrosis in knees - and now feeling in all joints.    Unknown if permanent damage - specifically for joint pain.
This spontaneous report as received from healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received with a dose of ROTATEQ (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 minutes for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports received from the same source. Additional information has been requested.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a three years old male patient who was vaccinated with an expired dose of IMOVAX RABIES (batch number M12962M, expiration date 12-JUN-2018) (dose, route and site of administration was not reported for vaccine) on 20-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. The patient did not experience any symptoms. 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.
Puffy, swollen eyes.  Hives all over body. Every single part of my body. Been going on for 36 straight hours now. No relief. Treating with calamine lotion and round the clock benedryl. No breathing issues.
I got the flu shot and  Hep B shot and I felt chills, nausea, and I started to vomit on this afternoon 9/17/2021.
Soreness in Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in Arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness in Arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR- AE Outcome updated from unknown  to resolved .
Slight soreness in arm; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), via an unspecified route of administration on 22Jan2021 14:45 at single dose for covid-19 immunisation. Medical history included breast cancer from 2016 to 2016. The patient's concomitant medications were not reported. The patient experienced Slight soreness in arm. Outcome of event was unknown.
First feeling of throat closing up/narrowing, not the same feeling as a sore throat though. Then chills and fever for the rest of the evening and into the night.
One time event of Epitaxis for approximately 2minutes, started with heavy bleeding and then stopped approximately 2 minutes. Client states over 10 years since last nose bleed. Other symptoms included sore arm and fatigue for 1 day.
Vaccine exposed to -0.5 degree Celsius for 45 minutes with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Medical Information (Reference number- 00708411) and transmitted to Sanofi on 03-Aug-2021.  This case involves MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL] that were exposed to -0.5 degree Celsius for 45 minutes and a patient received a dose of received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, TUBERSOL (TUBERCULIN TEST), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and IPV (VERO) (lot R1F973M and expiry date:30-Oct-2021) exposed to -0.5 degree Celsius for 45 minutes.  On 02-Aug-2021, the patient received as dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  This was potential medication error case due to product storage error temperature too low (on same day).  It was reported that "the refrigerator temperature went down and Caller states that excursion was caused by the door being left open."  It was not reported if patient experienced any adverse 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 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.
Extremely sick with vertigo, nausea, headache, runny nose, mild fever. Sicker than I've ever been in my life. Couldn't even stand up.
PATIENT RECEIVED A PNEUMONIA SHOT. THE ARM BECAME RED AND A LITTLE SWOLLEN AT THE BACK UP TO THE ELBOW.
pt recv vax 7FEB98 & 18FEB98 pt devel about five to eight skin lesions & a fever;most of the lesions were located around the inj site;pt mom described the lesions as little blisters;
Patient started to have severe stomach aches and diarrhea.  Occasionally he would throw up.  this went on for about 3 or 4 days.  He had severe body aches and we took him to urgent care.  the doctor thought it was his appendix.  He referred us to Hospital and we took him to the ER.  ER administered IV saline and did several tests they could not find anything and we were sent home.  The next day he continued vomiting and having diarrhea so we took him back to the ER.  He was admitted on Sunday 2019.  By Tuesday night he was in the intensive care unit and was basically in an induced Coma for approx. 10 days.   They never could figure out what he had.  The amount of flutids they gave him once they figured out he was dehydrated to the point of death was too m mkuch and all most killed him (sepsis I think they called it)  He has since recovered and was
I had about 15 minutes of kaleidoscope vision, circling rainbow lights, in my right eye.
Patient received inj. at 2:50 PM on June 19, 2014. She called pharmacy at 5:35 PM stating her upper Rt arm was very swollen. She then went to local emergency room and was treated with ice, Ibuprofen, BENADRYL.
11AUG93 hive devel lateral to SC inject site immed; no other rash or hives devel, no breathing difficulty 15AUG94; pt devel no other adverse react;
Approximately 45 mins-1hr, she became lightheaded and dizzy. She also reported a sore throat. The day after she reported a temperature of 101 deg F and body ache. Said she spent most of the weekend in bed. 11/4 reported L ear pain, chest tightness, runny nose.
Consumer reported she had symptoms after receiving the 1st vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Consumer reported she had symptoms after receiving the 1st vaccine) 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.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer reported she had symptoms after receiving the 1st vaccine). At the time of the report, VACCINATION COMPLICATION (Consumer reported she had symptoms after receiving the 1st vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Client received Janssen dose after having already received a dose of Janssen and a dose of Pfizer
Patient complained about having a scab that won't heal at the injection site that started after the first vaccine. The injection seems to be given near the back of the arm (almost where a SQ vaccine would be administered).
Heart Rhythm problems increase infrequency after vaccination; Heart Rhythm problems increase infrequency after vaccination; Fever (Low grade); Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia (treated with ramdesivir during which he was coughing up blood.) in November 2020. Concurrent medical conditions included Dysrhythmias (heart rhythm problem which he has had for 6 years).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (Fever (Low grade)) and FATIGUE (Tiredness). On 22-Feb-2021, the patient experienced ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Feb-2021, PYREXIA (Fever (Low grade)) had resolved. At the time of the report, ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination), CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19 pneumonia: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that his heart rhythm problem which he has had for 6 years has gotten worse after vaccination. He used to have about 1 episode every month, it increased to about 1 episode every week after infection with COVID-19 and how now increase to about 1 episode every 2 to 3 days after the first dose of the Moderna vaccine.   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. No concomitant information was reported.; 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.
On 08/31/2022, FDA approved the bivalent booster vaccine. Moderna monovalent is not authorized for booster, outside of clinical guidance.
Dizziness about 5 - 10 mins after vaccination, and persists for several hours up until filling out this form.
Phone call from client 1/7/08.  Complains of pain @ injection site immediately with vaccine; rested arm for "a few days" then restarted yoga, stretching & exercising.  Pain has continued & noted some weakness in arm "when lifting sideways".  As of 1/24/08, it is still painful but patient has not yet been to MD.
Refusal to bear wt on (L) leg & tenderness to touch at injection site within 12 hrs of flu vaccine being given in (L) leg. MOTRIN helped some.
- mild fatigue lasted 2 days - increased body temperature , 99.0 (taken using forehead thermometer) lasted 2 days - mild headache lasted a few hours - mild rash across chest started  5 days after vaccination
This spontaneous report was received from a nurse refers to multiple patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, multiple patients were vaccinated with VAQTA (lot # J009051 and expiration date 22-SEP-2016, reported as 20-SEP-2016) post supported temperature excursion. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an elderly male patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, headache and injection site pain. On an unknown date, the outcome of the injection site erythema, headache and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site erythema, headache and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had experienced injection site redness that extended down to the elbow of the vaccinated arm and was painful to the tough. The patient also had a mild headache.
was really dizzy; that was because of my nervousness; lips were tingly; was lethargic the whole week.; pain where I got the shot; chills; week later, I had fever; glandular pain under my arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly), AXILLARY PAIN (glandular pain under my arm) and LETHARGY (was lethargic the whole week.) in a 43-year-old female patient who received mRNA-1273 (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly) and LETHARGY (was lethargic the whole week.). In March 2021, the patient experienced AXILLARY PAIN (glandular pain under my arm), INJECTION SITE PAIN (pain where I got the shot), CHILLS (chills) and PYREXIA (week later, I had fever). At the time of the report, DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly), AXILLARY PAIN (glandular pain under my arm), LETHARGY (was lethargic the whole week.), INJECTION SITE PAIN (pain where I got the shot), CHILLS (chills) and PYREXIA (week later, I had fever) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.  A week later, patient experienced fever, chills, glandular pain under arm and where the shot was and lethargic the whole week. Allergist recommended not to get the second shot and recommended to get J&J. But then J&J got discontinued. So now, Is it okay to get the second Moderna vaccine since passed the timeframe