chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was treated for postherpetic trigeminal neuralgia; the patient was treated for zoster; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-MAY-2015, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy for or the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's vaccination, the patient was treated by a physician zoster and postherpetic trigeminal neuralgia. As a direct and proximate result of patient's vaccination, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The outcome of the events was unknown.
giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt. screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking/No AE; giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt. screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking/No AE; giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt. screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking/No AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], she was giving a patient a fluzone high dose and almost half of the dose came off on her shot and shirt. Screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given this visit.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ236AA, Expiry 04/04/2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to Exposure via skin contact and vaccine underdose.  It was also the case of syringe leak.  Reporter was giving a patient a Fluzone High Dose and almost half of the dose came off on her shot and shirt. She described screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking. She stated the leaking must have come from the barrel of the syringe on the side or perhaps the orange part of the needle because that is where her finger was resting. No damage noticed to the syringe or carton. Rph mentioned the other doses in the carton were fine to administer.  At the time of report 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.  Documents held by sender: none.
On June 4, 2008 in our immunization clinic, six children received their second dose of varicella. We are assuming one of them received a ZOSTAVAX instead of VARIVAX due to the count at the end of the day. All parents of the children were reached by 06/11/2008. None of the children had any adverse reactions, even a local one at the site of the VARIVAX. Since we are not positive that one of these children received a ZOSTAVAX, we are only giving you the names and birthdays of these children as instructed by WV Immunization Program. If you need more information, please contact me. I called CDC on 06/11/2008. In response to this situation, there was no specific answer in the literature, but the "expert" that was consulted stated that the dose of ZOSTAVAX, if given, should be "counted".
erythematous rash 7cm, began @ site (rt arm) of inj 72 hr p/inj;rash spread onto rt adjacent chest;rash persisted for several days;
Swelling to the right arm. Swelling was 2 in x 2 in.
Initial report received 13 November 2009 from a consumer, who is also the patient. A 58-year-old female patient with a history of multiple drug allergies, had received an injection of H1N1 2009 vaccine - Preservative (lot number, route and site not reported) on 13 November 2009 and approximately 45 minutes later, she felt weak, dizzy, flushed, hot, sweaty, "felt like eyes dilated", and her heart was pounding. Three hours later she continued to feel weak, hot and shaky, and her heart slowed down to sometimes feel like it skipped a beat. The patient contacted her health care provider, but was not evaluated. The patient stated that she would call her health care provider back if her symptoms worsened or "if they continued to last". The patient had previously received a Flu vaccination (manufacturer, lot number, route and site not reported) during October 2009. At the time of the report, the patient had not recovered. Documents held by sender: None.
injection site area became increasingly  itchy  evening of 6/8, (1 week post vaccination) and more tender than it had been previous 2 days,  Next morning (6/9/21 , today) woke up with a red rash , ~ oval , ~ 3" x 4 " , extremely itchy, tender and slightly warm to the touch.  barely any swelling. Responded to topical applications of hydrocortisone cream (1%) and Caladryl lotion (calamine + benadryl ) which reduced itchiness for a few hours.  Area remains slightly tender to the touch. Still getting itchy when the lotion wears off.
Cough starting an hour after injection. Feeling of heart racing (unverified, no oximider available), feeling of 2 heart palpitations, and shortness of breath around 1hr and 20 minutes after injection.
Pt. was slumped over to Rt side, skin pale, cool & clammy to touch, c/o severe pain to Rt arm, cool compress applied to forehead & feet elevated, v/s unable to obtain B/P x3, P 68, SPO2 97%.  EMS responded, wheezing auscultated x3 lobes, albuterol breathing Tx given, EMS transported pt to ER for evaluation.
A pharmacist reported that a 43-year-old female received an injection of Flu Shield (2001-2002 Formula) on 26-Nov-2001 and the next day, developed redness, heat, pain,swelling and itching at the injection site. The patient was seen in the emergency room and a diagnosis of cellulitis was made. The patient was prescribed unspecified antibiotics. The reporter indicated that the administrator of the vaccine "did not swab" the injection site "with alcohol" prior to vaccine administration. This is 1 of 3 patients from this facility who experienced an adverse event following receipt of Flu shield (2001-2002 Formula) lot 4018040. Additional information received 28-Dec-2001 indicated that the "condition on arm cleared", however, the patient developed infectious blisters on her face. The unspecified antibiotic that had been initially prescribed was changed. The blisters and arm swelling abated in less than a week following administration of a different (unspecified) antibiotic. See MCNs: HQ9047703DEC2001 and HQ9984821JAN2002.
L upper arm swelling and pain x 2 days. 1 week later developed pleuritic midsternal chest pain radiating to right shoulder. Work up showed pericarditis
Got mist 11/4 around noon.  Thurs pm (2 pm) headache & fever @ school.  Not at school Fri - headache.  Kept getting worse.  Had fever, went to after hours clinic:  102.7.  Didn't have flu - "H1N1 test neg @ hospital".  Severe headache, rash when in water & fever.  Admitted to hospital Tues-Fri. 11/19/09 DC summary and MR received for dates 11/10/09 to 11/13/09. DX: Aseptic meningitis, rt. middle lobe pneumonia, sinusitis.  Pt presented w/ c/o HA, fever, rash.  Pt. states H1N1 vax 5 days ago. Assessment revealed nasal irritation, (+)pneumonia, pt. admitted for further eval. Pt. stable at DC.
red itchy rash at the injection site; red itchy rash at the injection site, 2.5 inches in diameter now, has gotten larger; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE PRURITUS (red itchy rash at the injection site) and VACCINATION SITE RASH (red itchy rash at the injection site, 2.5 inches in diameter now, has gotten larger) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (red itchy rash at the injection site) and VACCINATION SITE RASH (red itchy rash at the injection site, 2.5 inches in diameter now, has gotten larger). At the time of the report, VACCINATION SITE PRURITUS (red itchy rash at the injection site) and VACCINATION SITE RASH (red itchy rash at the injection site, 2.5 inches in diameter now, has gotten larger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
nothing known as of yet. pt has been contacted she was given two HD flu shots instead of one flu + one prevnar
One or more nosebleeds per day for 4-5 days (started about 4 days after vaccine).  I rarely get nosebleeds. Lower back pain. At first it was more intense and painful to even walk. This started 3-4 days after my vaccine. After about a week it lessened, but it's still present 3.5 weeks later. My period is very regular since I'm on birth control, but my period started a couple days early after getting the vaccine. It started about 6 days after my vaccine.
Patient presented initially with  complaint of skin irritation and tingling around neck,  and right upper extremity.  Patient was moved to observation chair and evaluated by PA-C.  Vital signs BP: 130/76 P: 68, R: 14, SPO2 100. Oral Benadryl 50 mg was administer.  After 15 minutes of observation the patient began to complain of  increased sensation of tingling and irritated skin extending further down right upper extremity, neck chest and lower right extremity.   10 mg dexamethasone was administered IM.  Patient care transferred to local EMS for transport to local emergency room.
fast heartbeat; asthma attack; Full body is aching; I had booster shot of Pfizer, and first two shots were of Moderna; first and second shot/Moderna; first and second shot/Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Nov2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (First dose), for COVID-19 immunization; Moderna (Second dose), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 2021, outcome "unknown" and all described as "first and second shot/Moderna"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "I had booster shot of Pfizer, and first two shots were of Moderna"; HEART RATE INCREASED (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fast heartbeat"; ASTHMA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "asthma attack"; PAIN (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Full body is aching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, asthma, pain.  Additional information: For Taking the pain relief medicines (Unspecified medications) but after every two hour like I get relief for only two hour and again after two hours I experience all the same symptoms: Unspecified  QR Comment: Reporter type could not be probed over the call as the consumer was unwilling to share any further information, hence captured by default as consumer or other non-health professional in tab. Since majority of the information was provided by the consumer itself, so 'is patient also the reporter?' checked as yes in tab.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a Registered Nurse (RN) who refers to a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL 9, intramuscular, lot # M018810, expiration date: 28-MAY-2018 (strength, dosage, and anatomical location were not reported) for prophylaxis.  Other suspect and concomitant medications were not provided. No PQC was involved. No adverse effects were reported. This is one of three reports from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004135: US-009507513-1612USA004136.
I believe vaccine went in to my shoulder joint.  I had a localized pain in the joint to the left of the injection site that lasted 5-6 weeks.  My range of motion was also affected. It has resolved now.
Child (last seen on 2/16/12) with full body macular rash after 4 yr old shots one month ago (1/16/12). Suspect MMR. Rash began on about 2/13/12. MMR on 1/16/12 - Merck - Lot 0568AA - L thigh SQ (2nd dose).
Headache & Myalgia Narrative:  Used OTC Aleve.  Other Relevant History:
Two week following the injection developed shortness of breath, which got worse and worse.  Made appointment with PCP , followed by  Chest x-ray, Echo, which showed Pulmonary artery HTN and made the doctor order a cardiology consult.  While waiting on the appointment the shortness of breathe had worsened to the point of needing to admitted to the ER.  Could only walk a couple steps until extremely short of breath.  Was admitted where several clots were found in my lungs.   completely occluding one of the pulmonary arteries.  They started  infusion of blood thinners directly into the clot, and started on oral blood thinners.  The echo improved following the infusion .
This case was received from a health professional on 26 November 2007.  A male patient (age unspecified), with a history of gastrointestinal upset following egg consumption, received an intramuscular left deltoid injection of Fluzone (lot number U2527AA) on 19 November 2007.  Approximately 24 hours after vaccination, he complained of pain in both elbows.  On 21 November 2007, approximately 48 hours after vaccination, he developed a sore throat and mild, generalized muscle aches.  On 24 November 2007 he presented to the emergency department with pain and muscle spasms from his elbows to his fingertips, and decreased muscle strength in both arms.  Upon admission, his CPK was noted to be elevated at 2000 (units and reference ranges not provided).  Treatment included three doses of Benadryl, intravenous fluids, and cardiac monitoring.  The patient was discharged on 25 November 2007, at which time his symptoms were noted to be "greatly improved".  Per the reporter, the patient had no other medical history, was not ill at the time of vaccination, and was not taking any concomitant medications.
This spontaneous report has been received from a licensed practical nurse referring to a 4 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of -7 Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011002: US-009507513-1701USA011004: US-009507513-1701USA005479:
extremely exhausted/ tiring easily; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07May2021 07:54 (Lot number: FB EW0171) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: I have epi pen. Concomitant medication(s) included: ADVIL COLD & SINUS; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (Dose: 1, 08:11 AM, Upper right arm, ROA: IM, Batch/Lot number: FB- EW 0158), administration date: 16Apr2021, when the patient was 60 years old, for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 07May2021, outcome "recovered" (May2021), described as "extremely exhausted/ tiring easily". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional information: Facility type vaccine: Hospital. Patient was extremely healthy before vaccination. Other vaccine in four weeks: No. Other medications in two weeks reported in concomitant medications. Covid prior vaccination: No. Covid tested post vaccination: No. Patient had reported Adverse event which has been over a month since her second injection. Patient slept like a dead person and was exhausted when she woke up and recently had enough energy to workout.  No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-DEC-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or approximately 01-MAR-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Hands started to ache a couple hours after vaccine, then later that night had shivering, headache, body aches, nausea. Noticed rash on torso and neck by Thurs 6/14, which lasted until Sunday. Then noticed red marks (looked like bug bites) on Sunday 6/17, then Monday morning of 6/18/18 had hives on back of arms and legs. I have had itching on legs (mostly shins) ever since.
One day after receiving, DTap, HIB, Prevnar, and IPV the infant developed high pitched screaming and then became limp and unresponsive (HHE) for <10sec.  These episodes occured 2-3 times in a 30 minute period. No apnea noted.  No cyanosis.  Well appearing.
This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M039202 with expiration date on 11-APR-2018 and lot # N005796 with expiration date on 26-MAY-2018 (dose and route of administration were not provided) for prophylaxis. The doses of VAQTA were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C (13.5°C), during a time frame of 5 hours 47 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009398: US-009507513-1709USA009399.
lump at injection site; Both hands swollen; sore throat; Fever; Swollen Arm at Injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever) and VACCINATION SITE SWELLING (Swollen Arm at Injection site) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). On 09-Mar-2021, VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071028:
Patient has a temperature of 99-100 degrees F, is vomiting and experiencing chills and aches.
2 days after receiving the vaccination she had flu like symptoms, body aches, fever chills. 3-4 days later, felt better, then 9/30, got cold that went away, but had symptoms of fever, extreme fatigue, naggy cough, lack/ no appetite. She still feels sick and has a lot of coughing, but the coughing has been getting better.
Weakness in muscles, joint pain, muscle pain and aches affecting movement, injection site pain, tiredness/fatigue