chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEAVY BREATHING/SHORTNESS OF BREATH; MILD CHEST PAIN; INCREASED FATIGUE; ITCHINESS TO RIGHT LEG; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included hospitalisation, and blood transfusion, and concurrent conditions included cardiac blockage, non smoker, non alcohol user, and low hemoglobin (3/10), and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered to left arm on 18-MAR-2021 15:00 for covid 19 prevention. Concomitant medications included fexofenadine hydrochloride for drug allergy.  On 18-MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported. On 18-MAR-2021 15:00, the subject experienced itchiness to right leg. On 19-MAR-2021, the subject experienced heavy breathing/shortness of breath. On 19-MAR-2021, the subject experienced mild chest pain. On 19-MAR-2021, the subject experienced increased fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchiness to right leg on 18-MAR-2021, and had not recovered from increased fatigue, heavy breathing/shortness of breath, and mild chest pain. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a physician concerning an 18 month old male who was vaccinated with the second and third doses of Hib. In 2000 the pt experienced Haemophilus influenza type b meningitis and was hospitalized. Medical attention was sought. the pt was hospitalized a the time of the report. The pt as doing well.
Moderna COVID-19 Vaccine EUA Vaccine administered to 17-year-old, which is less than recommended. No adverse events were reported.
Began to feel weak, felt as though going to faint, became cool and clammy, BP 100/70 P 46, O2 Sat 100% on room air, no loss of consciousness.  Taken to ED - noted patient did not eat prior to getting the vaccine
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 14-SEP-2017, the patient received an improperly stored dose of ZOSTAVAX 19400 plaque-forming units (PFU) (lot # M037013 with expiration date at 22-NOV-2017; for prophylaxis; route of administration and anatomical location were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # M024781 with expiration date at 21-FEB-2019). The administered dose of vaccine was exposed to a temperature between 6 Fahrenheit (F) degrees and 14 Fahrenheit (F) degrees for 11 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved.   Additional information has been requested.
Left thigh with erythema, edema, slight tenderness, warmth, noticed the next day by mom at 2 inches and by 24 hrs later was double size. They had only iced it prior to being seen.
Patient is 17 years old and was given Moderna vaccine instead of the Pfizer vaccine for the second dose. Patients first Pfizer dose was on 02-19-2021.
Cold; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A 52-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EP77534) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination the patient experienced cold. Patient stated that she scheduled this morning at 10:20 to receive her second dose. However, she had a cold. So, she wanted to know what happens next. She need number to reschedule her 2nd dose. Outcome of the event was unknown.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 12 month old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
After my son received 4 year old shots he stopped cooing, his motor skills weren't great his milestones took longer than normal kids his age. At 12 mo he was still and up to date non verbal! Diagnosed with severe autism at 22 mo. He's taking speech therapy and soon starting ABA therapy. I am the mother of patient on November 17th, 2015 my son went in for a 2 month well check in which he was weighed, measured and evaluated also given 3 vaccines and 1 oral medication for chronic constipation. Everything went well. February came around and my son was once again due for a well check (4 months old). We went in same routine and once again he was given 3 shots and 1 oral medication. After all was done the administrator or head of health center came in and apologized and informed me that the nurse saw and caught that at our previous visit my son was given the wrong shot. I was hurt and confused and till this day I still am, my son was given a 4 year old shots supposedly when he was  2 months old. That day she gave me a sheet and she said that it was for my record to show they weren't hiding anything. I left and switched my son's pediatrician. Fast forward 19 months later I went in to that clinic to sign off on medical records for my personal use and after a small hassle I realized I was lied to by the administrator! In the form she gave me the "wrong shots" weren't listed because they were not given when he was 2 months old they were given when he was 4 months old. And the lady who helped me get his records on 7/27/17 confirmed it for me. My son was severely impacted by these vaccines that were actually given when he was 4 months old. My son stopped cooing his motor skills were not good and his milestones took time to reach and on 7/5/17 my son was diagnosed with Autism Spectrum Disorder. My son is non verbal has severe constipation problems he wasn't the same baby after that. He now takes speech therapy thru program and is soon to start ABA therapy my son to this day is non-verbal! I never heard my son coo after that day. I'm seeking the help of VAERS because someone recommended you guys to help me with this misfortune I was lied to and when I tried to report it they said "things like this happen a lot" and that I couldn't do anything about it. I will be sending some proof that I got from the clinic and his immunization record I hope to hear from you guys with a solution all I want is justice for my baby who isn't the same since then. This left us with a financial burden me not able to work and left patient's dad to bring in the income.
Sweats; High pitch tone; Rash from neck to ankles that is pink/red in color; Breast feel heavy(feels like increased a cup size); menstrual period after second dose was also early; rash looks like a scarlet fever rash; Headache; Cold(Teeth chattering); Joint pain; Body ache (like run over by a truck); 102F fever; Breast area and neck lymphnods feel swollen; ringing in ears; Today 5/7 the rash is still there but fading; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)) and MENSTRUAL DISORDER (menstrual period after second dose was also early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A or 037B2HA and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), CHILLS (Cold(Teeth chattering)), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading). At the time of the report, HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment includes Tylenol , Benadryl.   This case was linked to MOD-2021-114267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No specific follow-up information recorded.
Body aches and fever up to 102 degrees. Patient reports she noted tender lymph nodes under both axilla and in the breasts - right side worse than left. It is still present
foaming of the urine; severe edema of the legs; Minimal change disease; Chronic kidney disease (CKD stage 2); This case was reported in a literature article and described the occurrence of minimal change disease in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.  Concurrent medical conditions included hypertension.   On an unknown date, the patient received Influenza vaccine. In June 2018, 15 days after receiving Influenza vaccine, the patient experienced minimal change disease (serious criteria GSK medically significant) and chronic kidney disease (serious criteria GSK medically significant). On an unknown date, the patient experienced foamy urine and leg edema. The patient was treated with prednisone. On an unknown date, the outcome of the minimal change disease, chronic kidney disease, foamy urine and leg edema were recovering/resolving.   The reporter considered the minimal change disease, chronic kidney disease, foamy urine and leg edema to be probably related to Influenza vaccine.     Additional Information: GSK Receipt Date: 17-JUN-2022 Author Comment: The patient's age was 54 years at the time of reporting. The patient was had a medical history of hypertension. The patient provided informed verbal consent for her case to be presented. In 2018, the patient received Influenza vaccine. She was initially diagnosed with minimal change disease (MCD) in June 2018, approximately 15 days after receiving the influenza vaccine. The initial presenting symptoms included foaming of the urine and severe edema of the legs. The diagnosis was made following a kidney biopsy. After a course of prednisone therapy, she remained in remission for 4 months. However, she relapsed in October 2018 and was deemed to be in remission after being treated with prednisone the second time. She was tapered off the prednisone over the next 3 months, after a 6 months taper was originally planned. However, the patient experienced moon facies and blistering skin as adverse effects of taking steroids, so she requested a shorter taper period. She was diagnosed with chronic kidney disease (CKD stage 2) after the first episode of MCD. She remained in remission for over 3 years following treatment with steroids. She did not receive the influenza vaccine or any other vaccine during the time she was in remission because she was concerned about a relapse. She chose to receive the Pfizer vaccine against COVID-19 because she worked in healthcare and had reactivation of MCD after receiving the Pfizer vaccine.  The development of MCD has also been reported after influenza, hepatitis B, pneumococcal, measles, and tetanus-diphtheria-poliomyelitis vaccines. There have been various cases of reactivation of MCD after the administration of the influenza vaccine. The exact pathogenesis of MCD following influenza vaccination is not known; however, it is plausible for immune complexes to form or deposit in the subepithelial space because of the interaction between the influenza vaccine antigen and native antibodies, leading to this pathological process.
It started light headedness and nausea. Went to headache and fever of up to 101.
Numbness/tingling in fingers; Back pain; Numbness and tingling on side of face; headaches; lips feeling sore; lips feeling swollen; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was not available. The patient had BACTRIM allergy. Concomitant medication included womens daily gummy multi vitamin. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 14:45, the patient experienced numbness or tingling in fingers immediately after vaccine. On an unknown date in Mar2021, the patient experienced numbness and tingling on side of face over past few weeks (mild) that was increasing but still had control of facial movement and also intermittent back pain but was still able to continue exercising routine most days. In week one, in Mar2021, the patient experienced headaches intermittently and week 2.5, she had lips feeling sore and swollen. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness/tingling in fingers, back pain, numbness and tingling on side of face, headaches, lips feeling sore and lips feeling swollen was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
In the evening p/given #1 hep B shot & mom reported fever 102.6;the next morning the fever was gone;mom states pt had adverse rxn to other childhood vaccines in past
feeling bad; clear cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (clear cough) and FEELING ABNORMAL (feeling bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthmatic.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COUGH (clear cough). On 21-Nov-2021, the patient experienced FEELING ABNORMAL (feeling bad). At the time of the report, COUGH (clear cough) had not resolved and FEELING ABNORMAL (feeling bad) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient was scheduled to take 3rd dose on 22-Nov-2021.
Information has been received from a physician concerning a 2-month-old male who was vaccinated by mouth with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that, within two weeks of vaccination, the patient developed diarrhea characterized by roughly 6-7 loose stools each day for approximately five days.  Unspecified medical attention was sought. Subsequently, the patient's diarrhea resolved. Additional information has been requested.
1st and 2nd dose Pfizer COVID vaccine given as the booster instead of the PFizer Bivalent booster
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 had no relevant medical history. Concomitant medication(s) included: HCTZ, start date: 01Nov2022. Past drug history included: Epinephrine, reaction(s): "drug allergies: Epinephrine".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Chest pain, shortness of breath, headache, dizziness, nausea, fever.  09/12/2007 MR received for DOS 9/6-7/2007 for admitting DX of allergic reaction MCV, dyspepsia, tachycardia.  Consult reports possible allergic reaction to meningococcal vaccine.  Diagnostic Impression:  MDD. Pt with agoraphobia.  Possible reaction to MCV.  Generalized anxiety.
Fatigue, joint pain and body ache within 5 hours of vaccination. Migraine, nausea, difficulty swallowing swollen lymph nodes within  18 hours of vaccination. Resolved with rest.
Developed a cold by the next morning, which quickly progressed into bronchitis. Severe headache for several days. Personality change (more angry and impulsive, attention issues that had not been an issue before).
a Possible adverse reaction with the vaccine/ she is currently taking Stelara/ this is a concern with regard to the interaction that happen with the drug and the vaccine; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer or other non-HCP.  A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 30Jan2021 as DOSE 1, SINGLE, second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 20Feb2021 as DOSE 2, SINGLE for covid-19 immunization; ustekinumab (STELARA, Formulation: unknown, Lot number was not reported), via an unspecified route of administration from an unspecified date and ongoing, at unspecified dose for immunosuppressant drug therapy. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced a possible adverse reaction with the vaccine/ she is currently taking stelara/ this is a concern regarding the interaction that happen with the drug and the vaccine. The outcome of event was unknown.  Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
My hands have no tactile sensation. every thing i touch is just there. I can not tell if something is hot, cold, soft, hard. the good thing is that they are not hurting me when i beat people up.
developed a rash in trunk area; tenderness at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash and injection site tenderness. On an unknown date, the outcome of the rash and injection site tenderness were not recovered/not resolved.   It was unknown if the reporter considered the rash and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed rash in trunk area and tenderness at the injection site the following day that received the first dose of Shingrix. The reporter did not consent to follow up.
11 yo was vaccinated with Flulavel Quad influenza vaccine (lot # 5EK43) on 11/9 at 1546.  Patient had NKDA and had received annual flu shots in the past.  No allergic reactions to egg or latex in the past.  No fever in the previous 24 hours. Minutes after administration at ~1550, patient had hives and erythema appearing bilaterally on face. Mom stated patient has been having hives appear on face recently but has no determined allergies. MD assessed.  Treated with diphenhydramine 25mg po.  Mother of patient refused to stay for observation.