chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left Ventricle Systolic Heart Failure; If she exercises, she gets tired; This spontaneous case was reported by a consumer and describes the occurrence of LEFT VENTRICULAR FAILURE (Left Ventricle Systolic Heart Failure) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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, the patient experienced LEFT VENTRICULAR FAILURE (Left Ventricle Systolic Heart Failure) (seriousness criterion medically significant) and FATIGUE (If she exercises, she gets tired). At the time of the report, LEFT VENTRICULAR FAILURE (Left Ventricle Systolic Heart Failure) and FATIGUE (If she exercises, she gets tired) outcome was unknown.            Concomitant information was not provided.  It was reported patient had one test after another, but did not take any no real treatment.  Company Comment: This case refers to a 49-year-old female patient with no known medical history who experienced the unexpected event of Left ventricular failure after an unspecified number days post exposure to the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.   This case was linked to MOD-2021-420776 (Patient Link).; Sender's Comments: This case refers to a 49-year-old female patient with no known medical history who experienced the unexpected event of Left ventricular failure after an unspecified number days post exposure to the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
patient got a booster dose instead of a third dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient got a booster dose instead of a third dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 006B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (patient got a booster dose instead of a third dose). On 20-Nov-2021, ACCIDENTAL UNDERDOSE (patient got a booster dose instead of a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included immunosuppressive agents.  Treatment information was not provided.
Bleeding vaginal; Spotting vaginal; a little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 14:30 (Lot number: FG3527, Expiration Date: 28Feb2022) at the age of 57 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: she just has eczema once in a while; "menopause" (unspecified if ongoing), notes: last period was in Apr2020 so it's been 17 months without anything at all; "vaccination" (unspecified if ongoing), notes: maybe 20 years ago. There were no concomitant medications. Past drug history included: Doxycycline, stop date: Oct2021, for eczema or a rash, reaction(s): "skin tingle", notes: stopped taking it at least a couple weeks before she got the COVID vaccine, like maybe Oct2021. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 11Nov2021, outcome "recovered" (14Nov2021), described as "Bleeding vaginal"; VAGINAL HAEMORRHAGE (non-serious) with onset 10Nov2021, outcome "recovered" (14Nov2021), described as "Spotting vaginal"; FATIGUE (non-serious) with onset 09Nov2021, outcome "unknown", described as "a little tired". Clinical course: She got her Pfizer COVID shot on Tuesday afternoon, 09Nov2021. She was fine, she may have been a little tired and she went to bed early that night, but it was no biggie. The next morning clarified as 10Nov2021, she noticed she had some spotting vaginal and thought this was weird. She stated later that night on 10Nov2021, kind of in the middle of night, she experienced full on bleeding. The caller thought wow, she doesn't think it's a coincidence. It had been 17 months since she had any bleeding. The caller clarified the bleeding began late the night of 10Nov2021, like in the middle of the night, so it was really Thursday, 11Nov2021. The bleeding lasted for four days until like Sunday. She verified she has recovered completely. The patient explained the bleeding lasted for about 4 days. She explained if she wasn't in menopause and she experienced the bleeding after the vaccine, it probably wouldn't have phased her. She would have thought it may have messed something up, but because she is menopause she thought it was kind of funky. Otherwise, she felt fine. She felt tired but it was no big deal. She stated she is a runner and she runs 5 miles a day and she did her morning run and did all of her normal stuff. The patient confirmed she experienced this after her first shot. Her second shot was scheduled on 30Nov2021. She was wondering if the bleeding will happen again, she will let Pfizer know. The events did not require emergency room and physician's office visits. She explained if the bleeding had kept on longer than 4 days, she would have called her gynecologist or a doctor.   Follow-up (19Nov2021): Follow-up attempts are completed. No further information is expected.
PT RECEIVED TWO DOSES OF DTAP ON THE SAME DAY BY MISTAKE NO REACTION OCCURRED AND PATIENT HAD NO ADVERSE REACTION AFTER 15 MINUTES OF WAITING AFTER VACCINE WAS ADMINISTERED.
Patient called pharmacy stating she thought she experienced a brief (couple hours long) episode of Bell's Palsy after receiving the Moderna booster dose.
positive COVID test 8/14/21; presented to ED from infusion center where she had been receiving antibody infusions since 8//18/21; complains of increasing chills, fever, cough, SOB, diarrhea; hx of diabetes mellitus type 2; acute hypoxemic respiratory failure due to COVID
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). It was reported that on an unspecified date, the patient developed redness at the site of injection after the administration of the vaccine. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
Syncope, flushing/sweating, vitals wnl. Given apple juice, graham crackers.
Severe itching on hands and arms up to elbow started about 6:00 and then began spreading farther up arms.  Took two OTC Benadryl and went to ER.  Received an injection of Solu-Medrol (IVP) IVP 125 mg and was told since I had already taken the Benadryl they were concerned if they gave me more, I would start shaking.  About an hour the itching has lessened substantially but did not go away.  Prescribed 2 Benadryl 25mg each every 6 hours for 3 days and 2 Prednisone 20mg eachfor 3 days.  Continue to have moderate to mild itching today.
7 month old child was given a dose of QUADRACEL/was to be given VAXELIS and PREVNAR 13 instead with no adverse event; Initial information was received on 23-May-2022 regarding an unsolicited valid non-serious case received from a patient via call center.   This case involves a 7 months old male patient who experienced 7 month old child was given a dose of quadracel/was to be given vaxelis and prevnar 13 instead with no adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [QUADRACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-May-2022, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid ACpertussis/IPV (MRC5) vaccine (lot C5970AA) (dose, formulation, strength, and expiry date: unknown) via intramuscular route in the left thigh for prophylactic vaccination.  On 23-MAY-2022 the patient developed a non-serious 7 month old child was given a dose of quadracel/was to be given vaxelis and prevnar 13 instead with no adverse event (wrong product administered) (latency same day) following the administration ofdiphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 7 month old child was given a dose of quadracel/was to be given vaxelis and prevnar 13 instead with no 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dizziness, Headache, Bilateral rib pain, back pain, chest pain Narrative:
Pt called son to let him know he couldn't breath around 2 AM.  Pts son showed up at his house 10 minutes later and ambulance arrived with in 20 minutes at 2:15
We both took our second Shingrix Shingles shot. During the night had chills. In the morning had headaches, 101.5 fever, fast heart rates ranging from 88 to 95 bpm. Light headed, body aches. We both had these symptoms.
Two hours after the vaccine shot on Dec. 10 at 3 PM I started to feel weak. Later on all classic flu symptoms developed: aching bones, weakness, running nose. No fever. Today is three days after the shot, I still feel poorly, no improvement. I was using Beconase spray to stop running nose, and tylenol to alleviate achiness. I have never had any flu shot reaction before.
The baby was noticed to have what the mother thought was bruising of the right thigh and lower leg the day after the immunizations were given. By the next day when she brought the baby for an office visit the rash had disappeared from the thigh and was fading on the lower leg. On examination the rash was erythematous with a lace-like appearance on the extensor surface of the right lower leg. There was also a 1 cm area of blue coloration on the lower leg. The rash had the appearance of a vasculitis. No treatment was given.
Patient became extremely faint immediately after the injection. Patient began to shake, got really hot, then really cold and felt as if he were going to pass out. Also said that his arm hurt & felt stiff at the injection site.  This feeling he described lasted about 15 minutes, then he began to start feeling a little bit better. We gave him some water and had him sit for as long as he needed. Patient sat for total of 30 minutes, then left of his on accord.
First two days after vaccine (6/5/2021 and 6/6/2021) I experienced rapid rise in fever, between 99 and 101 degrees.  It initially went away after a day.  However, the following weekend, my fever spiked again drastically and went as high as 103 at times, fluctuating up and down, and also causing me to be bedridden from chills and nausea.   I did not experience any symptoms such as sore throat, runny nose, difficulty breathing, vomiting or diarrhea.  As I had to stay in bed that following weekend from the fever, I also developed severe hemorrhoids that lasted about a week and became swollen with purple/blue color as if they were full of a blood clot.  The fever went away that 2nd weekend after taking Tylenol and Advil.  The hemorrhoids went away after using witch hazel soaked pads.  No further symptoms were experienced since June.  I also should note that I have not had any fever or flu symptoms in 1.5 years before taking the vaccine, and generally have been in good health up to that point.  I am not a smoker or clinically obese at all, or have other underlying issues.
14 Year Old Female Patient Was Administered A Moderna Vaccine Rather Than A Pfizer Vaccine. No Signs, Symptoms or Adverse Reaction Reported Day of Administration. Patient's Father Contacted & Patient  Followed Up Multiple Times. No Signs, Symptoms or Adverse Effects Reported To Date. 2/15/2022
in 3-4 days patient developed progressive chest pain with dyspnea / orthopnea, presented to local hospital and transferred to medical center, initially thought to be MI / STEMI, but diagnosed with myocarditis after left heart catheterization.
Pt declared after injection "I don't feel well" Eyes watered, slow to respond, c/o of back pain.  Placed on gurney and called a team alert
developed unprovoked DVT  in left popliteal vein.  Had leg cramps on left leg interior groin area.
The patient did not have an adverse reaction but in fact had was given vaccine outside of recommended temperature storage condition. The vaccine supposed to have been removed from the freezer into the fridge on 09-30-21 but was not moved until 10-09-21.  It was overlooked when being removed and given to the patient in error.
primarily n/v;also c/o h/a & body aches;seen by PMD;sx resolved w/in 48hr;
neuropathy on feet, arms, and chest; chills; fatigue; lack of sleep for the last 12 days; This is a spontaneous report from a contactable consumer, reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration at the left arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was administered at a military base. Medical history included hypertension (controlled with medication) from an unknown date and unknown if ongoing. There were no known allergies. There was no other vaccine in four weeks. Concomitant medication included lisinopril, felodipine and tamsulosin (reported as medications in two weeks).  On 04Feb2021 at 17:00, the patient experienced chills, fatigue, neuropathy on feet, arms, and chest and lack of sleep for the last 12 days. The patient was advised to drink plenty of water and take Tylenol. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The events required a doctor office and emergency room visits. The patient underwent lab tests and procedures which included influenzas A: negative, influenzas B: negative, both on unspecified dates; and COVID-19 nasal swab: negative on 08Feb2021, 11Feb2021 and 12Feb2021. The outcome of the events was not recovered.
Pt. was given vaccines and w/i 24 hours he experienced a seizure and was "lifeless" per mother. Taken to ER and took 2 hours to recover. Diagnosed with febrile seizure but never had a fever.
Eyes were burning; Fever; Headaches; Swelling at injection site; Redness on arm; This spontaneous case was reported by a patient and describes the occurrence of EYE IRRITATION (Eyes were burning), PYREXIA (Fever), HEADACHE (Headaches), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness on arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced EYE IRRITATION (Eyes were burning), PYREXIA (Fever), HEADACHE (Headaches), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness on arm). On 18-Mar-2021, EYE IRRITATION (Eyes were burning), PYREXIA (Fever) and HEADACHE (Headaches) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness on arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The individual felt faint / light headed as he walked towards his vehicle following 15 min observation period . He  Did not feel that he would be able to safely operate his vehicle . Returned to the observation area  Glucose levels were within normal range reading was normal. Blood Pressure reading and pulse were within normal limits. No abnormal respirations. Appeared flushed and slightly diaphoretic after additional 10 min of observation at vaccine site . Decision made at 3:30 PM to transport to the ER. Patient agreed
After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive.; After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Postural tachycardia" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive. Patient received vaccine. In 2 weeks no other medication was received by the patient. Patient have no known allergies. Paxlovid was taken from 10May2022 to 14May2022 for treatment of COVID-19 as an anti-viral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Seasonal flu shot and TB skin test given on 9/22/09. Injection hurt and remained sore for the week. By 9/26/09 I noticed it remained sore and felt my range of motion was being limited. ROM still limited and arm sore-after 4 weeks.
Rectal 103.8 fever for 14 hours. Pedialyte and Tylenol and Tipin bath.
Feel nauseous, sick to my stomach, chills, feverish, headache, itchiness.
Expired ActHIB vaccine administered on 10/9/23.  Saline diluent expired 10/7/2023.  ActHIB expired 10/8/2023
pt saw physician on 1/21/22 with c/o cough; positive COVID test; given zpack, prednisone, vitamin D and zinc; dc'd to home; pt died at home later that day; med records and death certificate emailed to VAERS per their request
rash down the arm at the injection site; felt extremely exhausted; extremely cold; This case was reported by a consumer and described the occurrence of injection site rash in a 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, unknown after receiving Shingrix, the patient experienced injection site rash, exhaustion and feeling cold. On an unknown date, the outcome of the injection site rash, exhaustion and feeling cold were unknown.   It was unknown if the reporter considered the injection site rash, exhaustion and feeling cold to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received the first dose of Shingrix and she experienced a rash down the arm at the injection site and was down for about 3 days (felt extremely exhausted, extremely cold). Reporter consented to follow up.
On 09/05/2001 a 13 year old male received a Lymerix vaccination. In September 2000, the pt reportedly received his first dose of Lymerix without adverse event. On 06-SEP-2001 the pt reportedly experienced a slight fever and 1/2 to 1 inch redness at the injection site. The reporter stated that the vaccine "was not in a clinical trial". As of 06-SEP-2001, the outcome of the adverse events was unknown.
Initial information received on 17-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 62 years old female patient who received 0.5 ml dose vaccine FLUZONE HIGH DOSE (batch number: UI981AA, expiry date, dose in series not reported) via unknown route in the unknown administration site on 15-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. No adverse event was reported. 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 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.
elevatedtemp 2SEP98, 104.3;rash began 5SEP98 started on face & went down torso;smal red raised bumps;9SEP98 rash receding;
Intermittent vibration (buzzing) in arch of right foot started approximately 23 minutes after the injection of the vaccine, and it is still occuring.
No additional AE.; An expired dose of PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) use as directed to prevent pneumococcal infection, product quantity 1, lot #U003306, expiration date: 15-OCT-2022, (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Expired product administered). No adverse events were reported.