chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; shingles in her eye; blind in that eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and unilateral blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and unilateral blindness were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and unilateral blindness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was known to the patient. The age at vaccination was not reported. The reporter stated that, any vaccine has side effect but he/she know a lady(patient) who had the Shingle shot and then got shingles in her eye.  The physician told the patient it was a side effect, blind in that eye now at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
I received the Pfizer vaccine first dose in my left arm. About 3 days after the first dose, my left arm (elbow to wrist) and left hand started to feel numb. This lasted for about a week. Then, the numbness was primarily on my left hand at the 4th and 5th finger.  (As I type this with both hands, I feel a tingling sensation in the 4th and 5th fingers on my left hand). It has been nearly 3 weeks, and my left hand still has a numbness. I had a virtual visit with my primary physician office (INOVA) and the physician said it is probably neuropathy as a result of swollen lymph nodes from the vaccine. The physician prescribed naproxen and said if the numbness continues, more testing needs to be conducted.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient felt abnormal (magnetized; can feel it in her chest and it moves), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt experienced pain at injection site during administration. Pt continued having arm pain she saw her MD who diagnosed bursitis that "may have been caused by vaccine. Pt was prescribed physical therapy."
Pt. diagnosed with chicken pox 2-24-04. Received varicella vaccine 5-16-01.
12/29 nausea, headache. 12/30 runny nose, sore throat, cough. All symptoms lasted a week
This spontaneous report as received from registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical reported. On an unknown date, the patients were vaccinated with improperly stored (in the temperature: - 9.1 degree Celsius) (Oka/Merck) VARICELLA lot# L045955 with expiry date: 17-NOV-2017 and lot # reported as M000762 with expiry date: 06-NOV-2018 (dose and frequency were not reported). The time frame that the (Oka/Merck) VARIVAX out of range was 1 hour and 21 minutes. Data logger was involved. Additional information has been requested.
nightime p/vax, mom states pt had an onset of severe h/a, nausea, vomiting, fever 102 ax, instructed to take to MD; MD suspected onset influenza; 4MAR93 h/a; t99;;
Patient received shot and then a minute or two later said he felt dizzy and sat down in a chair and then he went very pale, became sweaty and his eyes lost focus and he lost consciousness (blacked out) and he said later he felt numb and could hear our voices but not see us. I called 911 as soon as he began to lose consciousness and while I was on he phone with 911, he regained consciousness and had color in his face again and felt much better. EMS and the firefighters checked him out and all of his vitals were normal and he could walk upright just fine.
Began to have severe right sided pain-constant-pain increased next day and went to Urgent care and diagnosed with probable kidney. Stone-pain worse next day and went to ED-told same thing. On the third day, rash developed, and realized I had shingles. Saw PCP and prescribed antiviral.
Pt recv vax on 2/9/99; 8 hr post vax pt exp fever (104-105), symmetrical shaking, eyes half open, upward gaze, poor response
Broke out with body rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (broke out with body rashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (broke out with body rashes). At the time of the report, RASH (broke out with body rashes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported the patient took the mRNA vaccine and broke out with body rashes that lasted for over a year.   Treatment information was not provided.   Reporter did not allow further contact
Initial pregnancy report received from a healthcare professional on 16 April 2013. A female patient of unspecified age, had received intramuscular dose of ADACEL batch number U4612AA (Anatomical site of vaccination was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. The patient was pregnant. The patient's last menstrual period date was reported as 11 September 2012. The expected date of delivery (EDD) is 18 June 2013. The patient did not experience any adverse event. List of documents held by sender: none.
I started feeling like my heart was pounding, I went to the ER. EKG, CBC, and metabolic panel all came back normal. They diagnosed it as palpitations. The next day my primary care doctor sent me to the lab to check my thyroid and B6 levels. Thyroid levels came back normal. B6 was elevated. The day after the palpitations started they started to get less frequent and intense. It has now been over a week and they are almost gone and not very intense. I also contacted my Lyme doctor about it and she was not sure of the cause (this was before I had gotten back the information about my B6 levels being elevated, so I will talk to her about that at my next appointment).  During this time I was also having trouble with nausea and stomach pain. I do not know if this is related and I'm not sure of the cause. This issue has seemed to be resolved.
pt recvd vax in the AM; mom brought pt back in around 130 approx 2 hrs p/shot; pt cont to cry unable to get pt to stop; referred to clinic for eval; 5JAN93 still having fever-crying is controlled; MD felt pt only have DT in future;
Evening of injection, at the injection site, it felt sore and warm to the touch.  Started to turn red.  Upon wakening the next morning, the site was warm, red, raised and itchy.  It looked like a red hive, about the size of a 50 cent piece and upper arm was slightly swollen.  Third day  the redness spread across the arm, warm, sore and swollen.  The redness was going down into the elbow to wrist area.  My arm was quite swollen.    I contacted my PCP, and had a video conference that day.  I also sent photos of my arm to a chart website.   He saw my arm and ordered Prednisone 20 mg for three days; as he felt it was an allergic reaction to the COVID injection.  Also was instructed to continue with Benadryl, Tylenol and ice.  It took nine days for everything to subside.
pt recv vax 23JUL96 & devel a little rash on abd which looked like little red papules;It was also reported that 2 to 3 of the papules looked like they were turning into vesicles;low-grade fever;
Felt like sleeping all day; Rash; Fever; Muscle pain; chills; Nausea; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, muscle pain, chills, nausea and somnolescence.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) fever, muscle pain, chills, nausea and felt like sleeping all day.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever, muscle pain, chills, nausea  and somnolescence was unknown. Rash coded to Vaccination site rash.
Approximately 10 minutes after receiving vaccine pt felt cold, shaky, and chest felt "heavy". No SOB pt placed in recumbant position, VS WNL. School nurse administered Benadryl 125 mg, BP decreased 5mm, continued chest heaviness and rescue squad called.
6 days after vaccine administration, pt had acute anxiety, malaise, abdominal discomfort, sensory neuropathy, elevated D Dimer, serum calcium and ALT.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 4 months old patient of unknown gender. On 08-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Information has been received from a health professional concerning a 5-year-old male who on 25-JUN-2001 (Lot # 635662/1249K) and 04-OCT-2001 (Lot # 636263/1336K) was vaccination SC in the left arm with a first and second dose 0.5 mL dose of Varivax. Concomitant therapy that day included: a first (Lot # 630634/0103K), second (Lot # 639572/0733L), and third (Lot # 646899/0951N) dose of 0.5 mL MMR II on 25-JUN-2001, 04-OCT-2001, and 20-AUG-2004: a third (DTAa978a2), a forth (Batch # DTPa997A2) and fifth (Batch # 630A2) 0.5mL dose of Infanrix on 09-JAN-2001, 04-OCT-2001, and 20-AUG-2004; a third (T1186-2) and forth (X0707) dose of IPOL on 04-OCT-2001 and 20-AUG-2004; and a first (472555), second (474946), third (474946), and forth (474946) 0.5mL dose of Prevnar on 08-FEB-2001, 10-APR-2001, 25-JUN-2001, and 04-OCT-2001. Other vaccinations included: a first (Lot # 467-008) and second (Lot # 473-441) 0.5 mL dose of Acel-Imune on 30-AUG-2000 and 02-NOV-2000: a first and second dose of hepatitis A virus vaccine inactivated (manufacturer unknown) on 09-APR-2004 and 10-OCT-2003; a first (MSD-Lot # 634237/0289K-0.5mL) and second (MSD-Lot # 636994/1033K-0.5mL) and third (manufacturer unknown) dose of Comvax on 30-AUG-2000, 02-NOV-2000, and 26-JUN-2001; a first, second (U1270AA), third (U1557AA), and forth (U1936AA) 0.5mL dose of Fluzone; and a first (T0025-2) and second (R1422-2) 0.5mL dose of IPV MERIEUX on 30-AUG-2000 and 02-NOV-2000. On 05-MAR-2006 the patient experienced chickenpox. Subsequently, the patient recovered from chickenpox. No additional information is expected.
5MAY98 small pink area lt thigh reported by mom;6MAY98 raised red area;7MAY98 edema & red;
had the third shot two weeks ago; had the third shot two weeks ago; Hair loss; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3182) via an unspecified route of administration on 26Aug2021 (age at vaccination: 67-Years-old) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1284) via unspecified route of administration on 13Jan2021(age at vaccination: 67 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9262) via unspecified route of administration on 03Feb2021(age at vaccination: 67 Years) as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced had the third shot two weeks ago on an unspecified date, had the third shot two weeks ago on an unspecified date, hair loss on 02Sep2021. No therapeutic measures were taken for the event alopecia. The outcome of the event alopecia was not recovered, the outcome of the events off label use, extra dose administered was unknown.  Follow-up attempts are completed. No further information is expected.
he was sore; tired; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he was sore), FATIGUE (tired) and HEADACHE (headaches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05BF21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (he was sore), FATIGUE (tired) and HEADACHE (headaches). At the time of the report, MYALGIA (he was sore) and FATIGUE (tired) had resolved and HEADACHE (headaches) outcome was unknown.            No treatment drug were reported.   No concomitant medication were reported.   This case was linked to MOD-2022-467168 (Patient Link).
Pt uncle(guardian) called to report that patient was talking, began to stare blankly and then collapsed to the floor. Pt's guardian reported that "b/p was ok, afebrile, pupils were undilated, neg rash, neg whelps, neg respiratory distress. After a few mins he came to". Patient reports feeling "funny" prior to collapse. Patient also did not remember passing out.
myelitis; a patient received FLUZONE HIGH DOSE vaccine twice in a month; a patient received an expired dose of FLUZONE HIGH DOSE vaccine; Initial information received on 02-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a male patient (age not reported) who experienced myelitis, while he received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 17-Sep-2017, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI6848E and expiry date: 30-Jun-2017) via an unknown route at an unknown administration site for prophylactic vaccination and also a dose of same vaccine on 17-Oct-2017 (lot number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination from a hospital when he was in vaccine recovery program.  On an unknown date, the patient developed a serious myelitis unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  It is also a case of medication error due to extra dose administered and expired vaccine used. A patient received an expired dose of FLUZONE HIGH DOSE vaccine twice in a month.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for myelitis.  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.; Sender's Comments: An elderly male patient presented with myelitis following the overdose vaccination with expired FLUZONE HIGH DOSE. Time to onset is not clearly defined. Medical history, concomitant medication, and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Progressively difficulty swallowing, weakness in left hand and arm, left leg weakness, then right leg weekness. Dr said has Guillain Barre Syndrome. Treatment plasmapherisis x 5.
Got really ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got really ill".  Additional information: It was stated by the reporter that, 2 guys aged 25-30 got really ill after taking Pfizer Covid vaccine. This case refers to second patient from 2 guys.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021447081 same drug/AE, different patient
fever started 14NOV96 PM 103.8;mom states pt appeared shaky;
BP 190/85 10 minutes after receiving vaccine. Heart rate 94. Felt nauseous, clammy, and faint/weak.  45 minutes later BP was 144/85.  I went home.  Base line BP is 108/68. Normal RHR 72.  On June 25 BP 170/92 heart rate 98 couldn't stand without fainting, nauseous, weak, and cold.  Called 911 and was transferred to ER and treated.
Fever of 102, loss of appetite, inconsolable crying. Progressed to upper respiratory congestion and cough by 11/30/2014 with fever remaining. Diagnosed with "upper respiratory infection" and "ear infection" and placed on Omnicef.
Within half an hour to 45 minutes I experienced an aura (episode prior to a seizure). I have been seizure free for 7 years; controlled via medication. Later that evening I had a fever, chills and severe body aches, along with extreme fatigue. This continued for 2 days. Felt better by the evening of Friday, April 9th. I missed 2 days of work due to the reactions.
This non-medically confirmed spontaneous report (initial receipt 25-Oct-2013), concerns a male patient. The patient previously had received half doses of influenza vaccine as he had a sulfite allergy and would get sick if administered a full dose at one time. The reporter stated that the patient received half doses of the influenza vaccine every time he was administered it and he still got sick. On an unspecified date, the patient received a half dose of unspecified influenza vaccine (manufacturer and batch number not specified). On an unspecified date, after the administration of the influenza vaccine, the patient developed the flu, a sore throat and threw up. Outcome was not reported.
Went over pertinent information with patient including disclaimer regarding blood clots associated with J and J vaccine. Patient stated no issues and to proceed. When asked if there were any allergies or adverse effects from previous vaccine administrations, patient stated no issues at all. Once vaccine was administered, the patient immediately broke out in a deep sweat, and fainted. I immediately had one of my techs call 911, during this time patient started to seize/convulsions. We had patient at an angle while patient was convulsing. Once patient stopped convulsing, patient gasped for air and regained consciousness. I asked patient if she was doing ok and identified myself as the pharmacist. Patient stated that they remembered who I was but did not remember anything after the vaccine was administered. EMS was called and while they tried to set up a quick triage IV line, patient started to faint again but did not lose full consciousness. Patient was transported to ER.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 4/24/2023 Discharge Date: 04/25/2023 Presenting Problem: CHF (congestive heart failure)  CHF (congestive heart failure)   HOSPITAL COURSE: 70 year old pt. Of Dr. with past medical history of CAD with anterior MI in 2013, ICM EF 22% s/p ICD, hypertension, hyperlipidemia, obesity. Patient reported ongoing dyspnea on exertion, arranged for outpatient R/LHC that showed elevated filling pressures and cardiogenic shock.    Patient was admitted to AHF service and placed on RDT. RHC 4/24 showed RA 11, PA 54/28/37, W 33, FCI 1.6 (wt 110.9 kg). LHC showed MVCAD (100% occluded mid LAD, known occluded prox RCA not imaged). His CAD was unchanged compared to prior angiogram in 2013, continue medical management; ASA, statin, and BB.    Of note, on admit, patient tested positive for COVID. He was asymptomatic, stable on RA, supportive care continued. He had COVID in December, this is when all his symptoms started, COVID+ this admit may be from December infection.    Iron studies on admit consistent with iron deficiency anemia (ferritin 60). Given quick discharge timing, he did not receive any IV iron, IV ferrlecit was ordered 4/25 but patient refused, he did not receive any IV iron inpatient. Also with quick discharge he would have only received one dose of IV iron, evaluate outpatient for IV iron.     GDMT; given low cardiac output (FCI of 1.6), coreg dose was reduced. Entresto was increased. Added spiro. Dr. triggered patient for outpatient LVAD evaluation.    This patient was on the Diuresis Team and was stable but remained hypervolemic at time of discharge.  Patient was diuresed with IV lasix (40mg x1 and 80mg x1) then transitioned to torsemide 60mg daily.   Estimated dry weight is <107 kg. Weight on discharge is 107.8 kg. Consider patient for Cardiomems implant
Information has been received from a physician concerning a 32 day old patient who on unspecified date was vaccinated with the first dose of ROTATEQ. No adverse effect reported. Additional information has been requested.