chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from the consumer on 15 Dec 2009: This patient received FLUVIRIN on an unknown date and patient developed itchy red skin rash. The patient was also on EXFORGE for an unknown indication since unspecified date (since 3 weeks). The outcome of the event was reported as it was not known whether rash continued.
Pt reported rash over her body, swelling legs, arms, and back after 5 days receiving ZOSTAVAX vaccine. Pt is much better but still got itching.
Severe hyponatremia 2 to nausea vomiting and diarrhea. Rhabdomylosis,
patient received Moderna Booster Dose in place of Moderna Bivalent Booster Dose
slept longer; light dizzy spells/more severe dizzy spells on and off/Would feel dizzy when moves his head; tightness in head; palpitations; felt more tired when he would get up; redness by the bicep; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), ERYTHEMA (redness by the bicep), SOMNOLENCE (slept longer), DIZZINESS (light dizzy spells/more severe dizzy spells on and off/Would feel dizzy when moves his head) and TENSION HEADACHE (tightness in head) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Ischemic heart disease. Concomitant products included ATORVASTATIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red). On 16-Mar-2021, the patient experienced ERYTHEMA (redness by the bicep). On 18-Mar-2021, the patient experienced PALPITATIONS (palpitations), SOMNOLENCE (slept longer), DIZZINESS (light dizzy spells/more severe dizzy spells on and off/Would feel dizzy when moves his head), TENSION HEADACHE (tightness in head) and FATIGUE (felt more tired when he would get up). At the time of the report, PALPITATIONS (palpitations), ERYTHEMA (redness by the bicep), SOMNOLENCE (slept longer), DIZZINESS (light dizzy spells/more severe dizzy spells on and off/Would feel dizzy when moves his head), TENSION HEADACHE (tightness in head), VACCINATION SITE ERYTHEMA (Injection site was red) and FATIGUE (felt more tired when he would get up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.  .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Significant information included - Outcome for AE updated.
After the 3rd vaccination. It happened end of last fall. It woke me up out of my sleep around 1AM. I woke my wife up and told her something was wrong with my heart. We went to the ER by the time I got there it calmed down and they ran a bunch of test. They referred me to see a cardiologist and she put me through a a lot of test, physical stress test, EKG. They came back okay. I see her now every six months to a year. I also noticed that every once in a while I get a singular heart palpitation and reoccurred after the 4th vaccination. After the 4th vaccination I developed a very aggressive respiratory condition that is the worse at night. It lasts all day. My wife has the same thing as well. Overall the heart palpitations come here and there and I am still dealing with the respiratory condition.
Numbness in both hands. Still able to completely function - just annoying. Has lasted about a week thus far.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old male patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. It was reported that patient's facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. No Treatment information was reported.
Patient felt "lousy"; Patient couldn't do anything for 11 days; Patient felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient felt "lousy"), MOBILITY DECREASED (Patient couldn't do anything for 11 days) and FATIGUE (Patient felt tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (Patient felt "lousy"), MOBILITY DECREASED (Patient couldn't do anything for 11 days) and FATIGUE (Patient felt tired). At the time of the report, ILLNESS (Patient felt "lousy"), MOBILITY DECREASED (Patient couldn't do anything for 11 days) and FATIGUE (Patient felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported    This case was linked to MOD-2021-106981 (Patient Link).
patient received BOOSTRIX (TDAP) instead of the intended/prescribed product DAPTACEL with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old female patient who received boostrix (tdap) instead of the intended/prescribed product Diphtheria/15/Tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2023, the patient received a dose of suspect Boostrix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site as prophylactic vaccination instead of the intended/prescribed product Diphtheria/15/Tetanus/5 AC Pertussis Vaccine with no reported adverse event (wrong product administered) (latency: same day).  It was reported "Nurse reported that a patient received BOOSTRIX (TDAP) instead of the intended/prescribed product DAPTACEL. Since the vaccines are similar, would this affect the patient's DTAP schedule? The DAPTACEL was ordered but BOOSTRIX was given instead."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Shingles. Treatment to-date: Valacyclovir, Lidocaine topical 3%. Condition ongoing, pain, discomfort.
I had a normal reaction afterwards, I had a fever. A week later, I started to have ringing in my left ear. It has not resolved, I still have ringing in my ear. No treatment was given, I am still under doctors care.
He tested + for covid on 1-19-23 and was admitted at PRIVACY.  Had a  complicated course  including septic shock, acute on chronic resp failure, renal failure, pneumonia, pancreatitis  and  passed away on 1-26-23.     .    treated with Remdesivir  and dexamethasone but not barici due to ESRD
Fever tmax 101 night of administration, 4 days of muscle aches and fatigue on 1/3/2021 I had a fever at bedtime of 101.5, treated with tylenol and ibuprofen. Afebrile next day (1/4/2021) until evening, when I had a fever tmax 101.6 until 4AM. Took Tylenol and Aleve. Profuse night time sweating.
HEADACHE, COUGH, SORE THROAT, SNEEZING, STUFFY NOSE. FEVER, BODY ACHES
On 3/17/2021 I went to the ER, and I would not let them do a CT scan. We just thought I had diverticulitis because I had severe lower left flank pain. I continued to have that pain, although much less, over the next month and a half. Then I started projectile vomiting and having diarrhea on 5/3/2021 because of the pain. I was so sore that I went on clear liquids for a few days until I gradually increased my diet. My amylase was elevated but my lipase was normal. I had an ultrasound of my pancreas, and it was normal. I had a colonoscopy and that was normal too. I continued to have diarrhea for about two and a half months. I went to doctor who is a GI doctor. He gave me probiotics and prebiotics called Align and Benefiber. Those took care of it for a while. Then I got the Delta Covid variant in early August 2021 and had a fever and was sick for 10 days. I had low energy until end of September. Then my energy came back to normal. Doctor then did some biopsies of my colon and diagnosed me with Microscopic Collagenous Colitis. I am currently taking anti-inflammatory drugs to treat this and firm up my stool. I am also seeing an acupuncturist and taking herbs. I've noticed certain foods make the symptoms worse.
Resident have had multiple PNA tx with IM Rocephin and IV Zosyn, Difficulty in swallowing,  Elevated HCV RNA, 02/15 PCR Quant, ER visit following weakness and involuntary UE movements/jerking. Elevated amonia levels controlled with use of Lactulose. 02/22/2021 RUE and RLE extensive DVT. Worsening pressure wound and development of arterial wounds.  Admitted to Hospice on 03/31/2021. Resident deceased on  04/03/2021.
Pt was vaccinated with Pfizer-BioNTech COVID-19 vaccine EUA and told the vaccinating nurse that he "always faints around needles."  Pt was vaccinated and moved to post-vac area; he then began complaining of feeling "sweaty and hot." Pt chose to lie on the floor.  Pt's vitals were within normal limits.  Pt denied any chest pain, SOB, or other discomfort.  Pt lied on the floor for approximately 15 minutes and then stated that he was feeling better.  Pt was able to stand without assistance or dizziness and ambulate with a steady gait.  Pt left clinic in care of his wife and stated that he felt "back to normal."  Pt was advised to seek medical assistance if he began experiencing the same feelings again.
injection site pain; tiredness; headache; muscle pain; chills; joint paint; joint paint; injection site swelling; injection site was very red; nausea; nausea; super tired; arm pain in my right arm same spot from injection on left arm; This is a spontaneous report received from a contactable female consumer reported for herself that:  A 49-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ff2587), via an unspecified route of administration, administered in Arm Left on 20Sep2021 (At the age of 49 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included armour thyroid 90mg taken for an unspecified indication, start and stop date were not reported. The patient had allergy to levothyroxine, synthetic thyroid and Synthroid. On 20Sep2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint paint, injection site swelling, injection site was very red, nausea, blurred vision for 3 days, super tired, pain in the right arm same spot from injection on left arm. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering.    Follow-up attempts are completed. No further information is expected.
Symptom lasted approx 10 minutes. Pt does not have a hx to reaction to previous vaccines. Tightness chest and throst-difficulty breathing. Resp Depression and shortness of breath, face flushing, chest tightness.
Fever, headache, chills, muscle and joint pain in legs. Both Moderna injections have been administered by our local Pharmacy .  The side effects have only occurred since taking the 2nd injection of Moderna on 3-16-21. My fever has been ranging from 98.8 to 100 for about 12 hours now.  Drinking liquids but not taking any OTC meds to lower my temperature.  I will go to local hospital emergency room if fever/temperature gets above 102.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 19-FEB-2016, the patient received improperly stored VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported.  Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.
Mom stated child became aggressive and began screaming violent things(blood, and killing). Mom was able to take child to Local ER with assistance of police where they sat for 2 hrs. before "calming down". No meds. administered and no tx. given at the ER, mom stated never even saw a Phsyician because the ER was so busy?
This spontaneous report was received from a physician and a 68 year old female consumer with asthma, chronic obstructive pulmonary disease, anxiety and with no drug reactions or allergies. In approximately March 2015, "about a year ago", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported) in the left arm. Concomitant therapies included PREVNAR 13, Tdap and fluoxetine. The consumer reported that on 04-MAR-2016, "3 days ago", she experienced shingles in the form of a palm size rash on the back of her right leg. The physician did not receive treatment for the shingles. There were no lab diagnosis or studies performed. The physician reported that the patient was seen in the office on 07-MAR-2016 due to developing soreness and an unspecified rash on 06-MAR-2016 at the injection site of where the PREVNAR 13 and Tdap were administered. The outcome of shingles was reported as not recovered. The outcome of soreness and unspecified rash was unknown. Soreness and unspecified rash at the injection site were considered to be related to the vaccination with PREVNAR 13 and Tdap. This is one of several reports received from the same source. Additional information has been requested.
Begain scratchy throat day after vaccine, followed by cough, wheezing, hoarseness, tightness in throat and chest with some mucus, occasional headache, occasional nausea, shortness of breath, tired/weak, painful areas (about the size of my fingertip) across chest, abdomin, sides, back, shoulders, arm, neck, cheek under rt. eye, shooting pain across chest and down front of thighs upon coughing spasms.  Upon this date, I still have hoarseness, cough, some wheezing, although most painful areas have subsided.
Patient has Epi Pen due to history of anaphylaxis. She was asked to be observed for 30 minutes due to history.  She received her second dose of Moderna, then 20 minutes later she complained of cough and tickle in throat. She said she had experienced cough with the first dose.  O2Sat=94% and p=67.  Benadryl 25mg was given by mouth and now patient complained of lips tingling.  Her O2 sat dropped to 90% now 25 minutes after the vaccination. Nurse assessed that lungs were clear and no wheezing or tightness noted. Seven minutes later the patient stated she felt better and O2 sat was 94%.  She no longer had the lips tingling. She was discharged with no further complaints.
4/29/21 3:30 PM - Vaccine Administered, right arm soreness and fatigue throughout rest of day 4/30/21 12:00 PM - Woke up, fatigue, body and headaches, fever, chills, chest pain and tightness throughout day, intermittent naps 10:00 PM - Fell asleep 5/1/21 11:00 AM - Woke up, chest pain and tightness persists, other symptoms minimized 9:00 PM - Check into ER, underwent series of tests (blood work, EKG, etc.) - EKG showed serious heart problems 11:00 PM - Medevaced to second hospital 5/2/21 12:00 AM - Underwent cardiac catheterization, showed inflammation around the heart 1:00 AM - Sent to ICU bed to recuperate and heal from catheterization 9:00 AM - Given Colchicine, Ultrasound admininstered showing still lower than normal heart activity Mid-morning/mid-day - Given metoprolol 12:00 PM - Moved to regular bed, symptoms somewhat improving Rested 5/2/2021 6:30 AM - diagnosis of Myopericarditis ,  9:00 AM - Given colchicine and metoprolol, symptoms reduced 11:00 AM - Discharged
On 11/2/10 pm, patient reported she noticed a black ring on left deltoid which was gone by 11/3 7 am.  However, she instead found 4 slightly raised red blotchy areas, warm to touch, ranging in size from 0.7 cm x 1 cm to 2 cm x 3 cm.  In to clinic and temp 97.2F at 10 am with BP of 110/66 right arm.  Referred to MD. Saw Primary MD 10:45 am 11/3 who diagnosed as superficial infection or sepsis.  MD put her on Doxycycline 100 mg ii tabs po day one, then i tab po for the next 6 days.  Rash increased over next two days then slowly faded/resolved.  Patient completed antibiotic.
Patient received his first MODERNA Covid-19 vaccination on 4/18/2021. He came back to the pharmacy 5/15/2021 to receive his second dose, but was given the Pfizer -BioN/Tech vaccine inadvertently as his second dose. Patient is doing well, but was unaware of the wrong vaccine until the pharmacy discovered the mistake and called the patient. He is concerned about having enough immunity against the Covid-19 virus and wants to know if he needs a third dose . If so, which manufacturer? Pfizer or g back to Moderna?
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was healthy person taking no other medications. The patient experienced shingles 5 weeks ago after receiving Shingrix vaccine. The reporter had suspicion that the vaccine caused this even though she have read it cannot. The reporter wanted to know how long does she wait for the 2nd dose.
12 hrs after vaccination, I had chills. These continued for about 36 hrs. 16 hrs after vaccination, I also had a fever of 102.9, muscle aches and weakness. My temp. stayed over 102 for about 24 hrs. 20 hrs after vaccination, I had periodic sharp pains in my left side, just beneath my rib cage. I assume this was my spleen. These pains continued on and off for about 10 hrs. I had profuse night sweats last night (starting about 30 hrs post-vaccine). Those apparently did help bring down my temp to 99.8 by 8 a.m. today (41 hrs after vaccination). I'm still in bed nonstop, as the weakness and fatigue continue and as of today (Saturday) I also now have a pretty unrelenting headache and sensitivity to light. I've taken Tylenol throughout, as advised by those administering the vaccine. It barely touches the headache, though.
The patient called the pharmacy saying she experienced an adverse reaction the day after she received her flu shot. She stated a hard knot formed at the injection site the day after she received her shot. Her arm felt very heavy. The area of skin near the injection was itchy.
Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13248), via an unspecified route of administration on right arm on 11Jan2021 08:30AM at a single dose for COVID-19 immunization at workplace clinic. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medication included zinc and melatonin in two weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on right arm on 23Dec2020 7:45AM. The patient did not receive other vaccine in four weeks. The patient was not pregnant and was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site pain, joint pain, mild fever, headache, nausea and diarrhea on 12Jan2021 10:00AM. The events were reported as non-serious. The patient did not receive treatment for the adverse events. The outcome of events was recovering. The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.