chrisvoncsefalvay/vaers-outcomes huggingface dataset:
monoclonal antibodies and the Moderna vaccine with a 46 days of difference; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (monoclonal antibodies and the Moderna vaccine with a 46 days of difference) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (monoclonal antibodies and the Moderna vaccine with a 46 days of difference). At the time of the report, OFF LABEL USE (monoclonal antibodies and the Moderna vaccine with a 46 days of difference) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment related information has been reported. No concomitant medications were reported   Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included anaphylactic shock (after a red ant bite). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, rash, injection site pain and swallowing difficult. On an unknown date, the outcome of the fever, rash, injection site pain and swallowing difficult were recovered/resolved.  It was unknown if the reporter considered the fever, rash, injection site pain and swallowing difficult to be related to SHINGRIX. Additional details were provided as follows:  The reporter was husband of the patient. The patient stated that her physician had already reported this adverse event, however no duplicate case was identified. The age at vaccination was not reported. The patient received dose of SHINGRIX vaccine 5 to 6 weeks, before the date of reporting. For the first and second day, the patient had soreness at the injection site. She had a high fever, rash and difficulty swallowing. The rash was on her chest and upper thighs. The patient saw her physician twice for this reaction and stayed in bed for a few days because of the reaction. It resolved after one week. The patient was concerned that she might have a worse reaction after the 2nd dose so she did not plan on getting the 2nd dose of SHINGRIX.
In March I had Baker's cyst on back of knee. I was referred to an Orthopedist in April who discovered this to be rheumatoid arthritis instead and suggested that knee needs replacement. Then in May, I had a sudden flair up of rheumatoid arthritis, started in right side and ended up with both hands severely swollen. Right leg was twice the size of left leg.
On the night of 27 July I was awakened by a severe arrythmia, with conflicting beats.  I took an aspirin, and eventually my heart started to beat regularly again. Two nights later the same thing occurred, this time resulting in a near syncope. Inasmuch as the second occurrence was on a Friday night, I couldn't call the doctor the next day, but perhaps I'll call for an appointment on Monday--especially if this re-occurs.
pt recvd vax & noted left arm was swollen & pruritic; rash appeared following day;
After the vaccination in the right upper arm the patient experienced pain in the muscle and and shoulder joint. The aching pain persisted for two weeks after the initial vaccination. He was evaluated on 10/26/2020 with continued pain and did have an Xray of the right shoulder that was unremarkable and was referred to physical therapy for pain of the right shoulder.
redness on her face; swollen eye; stroke in her eye; This is a spontaneous report received from a contactable reporter (consumer, patient's husband) from medical information team for a Pfizer sponsored program (159558).  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Feb2021 (Lot number: EN6202) at the age of 75 years as dose 1, 0.3 ml single for COVID-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (blood pressure medicine). The following information was reported: ERYTHEMA (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "redness on her face"; EYE SWELLING (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "swollen eye"; OCULAR VASCULAR DISORDER (non-serious) with onset 2021 (also reported as 40 days after vaccination), outcome "not recovered", described as "stroke in her eye". The patient was advised by her allergist not to get the second dose so she didn't.   Follow-up attempts are completed. No further information is expected.
Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Patient did not have any reactions until Friday 11-17-2023 when she woke up with a very red, itchy, and hot arm at the injection site. Slightly swollen. She wanted me to report this. No other side effects to note, and has since improved.
-1st Covid vaccine received 04/16/2021 Lt arm. <48 hrs. later Lt arm/axilla and portion of Lt upper back very swollen and a large lump under axillary Lt painful. Lt arm difficult to raise above heart level due to very painful.
I felt a little tired; Dizzy; I got canker sores under my tongue and on my tongue and it hurt very much; I got canker sores under my tongue and on my tongue and it hurt very much; This is a spontaneous report from a non-contactable consumer (patient). A patient (unspecified age and gender) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6198), via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation; potassium chloride (POTASSIUM CHLORIDE, 750 mg for an unspecified indication); chromium picolinate (CHROMIUM PICOLINATE, 200 ug and still ongoing for an unspecified indication); phentermine (PHENTERMINE, 37.5 mg and still ongoing for an unspecified indication); hydrochlorothiazide (HYDROCHLOROTHIAZIDE, 25 mg for an unspecified indication). Reported that patient stopped taking the Hydrochlorothiazide and I stopped the Potassium Chloride after 2 days because it made me dizzy. So I still take the Phentermine and the Chromium picolinate. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201), on 15Mar2021 as single dose for covid-19 immunisation and experienced Little tired on the 2nd day. Reported that two weeks before that I had the 1st one and all I felt a little tired on the 2nd day but I don't know if this canker sores are from the Pfizer. Reported that patient took two medicines on Monday and I started it on Monday so there is a 50-50 chance that is the medicine or the Pfizer. On 18Mar2021, the patient experienced i got canker sores under my tongue and on my tongue and it hurt very much, on an unspecified date, the patient experienced i felt a little tired, dizzy. It was reported that reporter seriousness for I got canker sores under my tongue and on my tongue and it hurt very much, I felt a little tired, Dizzy was unspecified. Reported that 4 days after my 2nd shot I got canker sores under my tongue and on my tongue and it hurt very much because canker sore hurt. But it is a possible side effect because it was 4 days after the 2nd one. Thursday I got this canker sores though and in addition I started taking some extra pills different pills so I don't know if those pills caused me to have the canker sores. So that's why I say possible side effects. The outcomes of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
12/07/21 presents to ED for "SOB". PMHx of "HTN, DM, chronic hypoxic respiratory failure on 2L NC due to COPD, OSA, CKD stage III, HLD, CAD, and obesity"
No adverse event reported; Administration of dose three of GARDASIL 9 shorter than recommended interval; This spontaneous report was received from a healthcare worker, referring to a 26-year-old patient of unknown gender. The patient's historical conditions, medical history, concurrent conditions, drug reactions or allergies were not reported.  On 09-APR-2019, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot # R008163, expiration date on 18-NOV-2020 (dose, strength and route of administration were not reported).   On 29-MAY-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot # R008163, expiration date on 18-NOV-2020 (dose, strength and route of administration were not reported).  On 25-JUN-2019, the patient received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot # R008163, expiration date on 18-NOV-2020 (dose, strength and route of administration were not reported).   It was reported that the third dose of of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was administered within one month of dose two of of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), shorter than recommended (inappropriate schedule of vaccine administered). No adverse effects reported.
Received Varivax on 1/8/98. Diagnosed with varicella on 11/23/05.
red; itchy; rash/splotchy; A spontaneous report () was received from a Consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events splotchy/rash, rash, red/erythema, itchy/pruritus  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 10 Feb 2021, the patient experienced the events, arm had a rash and was red, splotchy and itchy.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events rash, splotchy, itchy, red was unknown
Rcvd Hepatitis B and Influenza vaccines same day (11/16/2005).  Diagnosed with Guillain Barre syndrome on 2/7/2006 after experiencing tingling sensations in hands/feet and increasing weakness and paralysis which started 2/3/2006. Discharge summary states dysphagia. msv
about 27 hr p/vax rash appeared on face-flat red rash covering face-didn't extend to any other area; the rest was flat red spots-hot to touch & itched; mom states was feverish-unable to take temp; didn't feel well; no other sx;
Client received 1st Pfizer injection on 1/11/2021 at different facility.  Client came to us to "start over" and my nurse signed off and vaccinated her with 1st Moderna vaccine on 3/24/2021.  No reactions.  Client had side effects including body aches, chills, feeling like passing out, migraine, and nauseous.  Cleared up within 24 hours.  Spoke to Shelly at IDPH, she stated let the client know, report as a vaccine error, and do not give her the 2nd Moderna vaccine, she is considered "complete."  I let the client know, she was fine with this.
Fever, joint pain, neck pain, nausea, vomiting and diarrhea.
The patient's arm was a little sore Monday evening after receiving the vaccine. Tuesday she had mild body aches and pains. The injection sight developed a lump under the skin about 1 inch in diameter and felt warm to the touch. Today (Wednesday) the injection site lump has increased to 2 inches and continues to be warm to the touch and she has developed a dull ache in the lower back which sometimes becomes a sharp pain. The patient used Tylenol and Ibuprofen alternating to help with the body aches and arm soreness Tuesday. Recommended continuing to use them alternating to help with the inflammation and pain but to add Benadryl and cold compresses to the injection site. The patient will be calling her provider.
spoke w/MD 12APR d/t redness in lt arm & swelling;t103.4 ax 12noon 12APR97;MD placed pt on med;not seen by MD;lt deltoid sl swollen, warm to touch & tender w/pressure 14APR97;
Got light headed, and nausea, then couple of hours later is still having the problem along with arm soreness if continues I will bring her to emergency room.
blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs.  Treatment details were unknown.  Action taken with mRNA-1273 was unknown.  The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 were unknown.; Reporter'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.
patient had swelling, redness, and pain on upper arm. patient tried advil and benadryl. pat went to urgent care. urgent care thinks its an infection
My heart rate was around 115/120. Heart rate still elevated even now nearly 10 hrs later; my lips and in my mouth was tingly; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 (Lot Number: EP7534) as single dose for covid-19 immunisation.  Medical history included Asthma, high blood pressure, anxiety, allergies: Peanuts, tree nuts, cantaloupe, watermelon, imitrex. Concomitant medications included sertraline hydrochloride (ZOLOFT); amlodipine besilate (NORVASC); budesonide, formoterol fumarate (SYMBICORT); salbutamol sulfate (ALBUTEROL).  The patient previously took first dose of BNT162B2 at the age of 39-year-old in Left arm on 23Feb2021 10:15 for covid-19 immunisation, lot number=EN6203. There were no covid prior vaccination, no other vaccine in four weeks, and no covid tested post vaccination. About 10 mins after vaccine the area around patient's lips and in her mouth was tingly. The patient's heart rate was around 115/120. Heart rate still elevated even now nearly 10 hrs later. Called Her primary dr. He sent patient to ER. The event onset date and time were 16Mar2021 09:30. Treatments were received including IV Fluids, Ativan. The events outcome was Not recovered.
Patient received her 2nd COVID vaccine on 3/31/21 therefore was fully vaccinated - on 8/24/21 she presented to clinic with symptoms of COVID 19 and tested positive
A spontaneous report has been received from a Health Professional concerning a 2 year old, male patient. Patient relevant history, concurrent disease and concomitant drugs were not reported. Patient received FLUMIST QUADRIVALENT (Intranasal) on 10-Oct-2014 and also experienced a bloody nose. Only occurred on left side or left nostril only. The patient recovered from the event of nose bleed on an unspecified date. The reporter assessed the event of nose bleed to be non serious.
Aunt noticed redness & swelling on the (L) arm at vaccine site 07/18/12 AM. Shot was given 7/17/12 at 1256.
Sore arm; Rash; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced sore arm(pain in extremity) and rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Headache  Throwing up Stomach upset, only ate toast  Sore arm Overall feeling lousy  Could not go to work
Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already; after he has already completed his 2 doses of Pfizer.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already) and EXTRA DOSE ADMINISTERED (after he has already completed his 2 doses of Pfizer.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already) and EXTRA DOSE ADMINISTERED (after he has already completed his 2 doses of Pfizer.). On 15-May-2021, WRONG PRODUCT ADMINISTERED (Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already) and EXTRA DOSE ADMINISTERED (after he has already completed his 2 doses of Pfizer.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported
Pt received tetanus vaccine instead of PPD when receiving TB skin test. Tetanus was given intradermally. Redness and swelling developed at the site no other complication.
Day after vaccine quater sized area of redness and bruising.  Two days after redness had spread over anterolateral thight, approx 3 inches in diameter with centeral bruising.  Patient acknowledges discomfort in office.
approx. 45 min following the shot, I felt my heart racing and felt very faint and dizzy.  My co workers described me as very pale.  I felt as if I were going to pass out.   The following day, I had flu like symptoms, pain in the arm and severe fatigue.  I did not go to work on that day.   With the second injection, I did have the same feeling of heart racing, approx. 45 min after the shot.  It was less that time.  I had flu like symptoms x 2 days.    There was some medical treatment in Feb/March for seemingly unrelated symptoms (UTI etc) ,and I did have a holter monitor done at some point.     In mid-april, I was having respiratory issues which I had believed to be linked to an asthma flare.  I was working with my pulmonologist x 2 weeks and did not have any improvement with the usual treatments, during that time I noted increase in shortness of breath and felt my heart pouding several times.    On May 3, I was sent to the ED with symptoms of severe shortness of breath, and heart rate in the 120s.  SInce that time I have cont. to become tachycardic with any exertion.  I was put on medical leave by my doctor.  We are cont. to be in process of work up of the cardio/pulmonary systems.  I cont. to have tachycardia with any form of exertion.  My heart rate can go into the 130s/140s when going up and down stairs.  I have not been able to work since beginning of May because I have a very active job.  When I become tachy cardic, I become severely short of breath, and can become dizzy and the symptoms have been ongoing for the past few months.    Please feel free to reach out if more info is needed.  I was intructed to file this report by the CDC agent who called me after my most recent V-Safe survery.
he gave a 2 day old expired PENTACEL vaccine to a patient with no reported adverse event; Initial information was received on 06-May-2021 regarding an unsolicited valid non-serious case from a other health professional in the  (GMI Inquiry number: 00590857).  It was reported that on 26-Apr-2021, a six month old male patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) (lot number: UJ162AB, expiry date: 24-Apr-2021) which was expired 2 days ago via intramuscular at an unknown administration site for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  At the time of report, no adverse event 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.
5/13 as per phone conversation with patient's mother, redness and swelling present left deltoid region size of fist. I instructed her to take son to be seen by provider. 5/14 Patient seen by provider; Benadryl 12.5 3 times a day. 5/15 swelling and redness decreasing as per mother (phone conversation). Patient active; no temp, nausea/vomiting. 5/17 Swelling and redness still decreasing as per phone conversation. 5/24 As per phone conversation with mother, rash and swelling gone.
Constant sounds in the head like metals for 7 months. Subsequent MRI and CT Scan, MRI revealed a "Mild Cerebral Infarct". By means of natural medicine processes and detox he relieved the noises. Currently, he continues to be observed for Cerebral Infarction.