chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she injected a patient FLUZONE QD NP  subcutaneously instead of intramuscularly on 20 OCT2020 with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional via call center.  This case involves a 16-year-old male patient who was injected with quadrival a-b vaccine [Fluzone Quadrivalent] subcutaneously instead of intramuscularly (incorrect route of product administration).  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2020, the patient received on influenza quadrival a-b vaccine (formulation, strength was unknown) (batch number: UT7041JA and expiration date: 30-Jun-2021) at vaccinated with 0.5 ml (once) via subcutaneously instead of intramuscularly (incorrect route of product administration) for prophylactic vaccination.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
This medically confirmed spontaneous report (initial receipt 07-Mar-2016) concerns an unknown demographics patient. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient experienced an anaphylactic reaction. The outcome was not reported.
Within 24 hours of receiving vax pt developed temperature of 102 with shaking. Pt also developed increased area of erythema, tenderness, swelling, heat and induration over injection site. Pt was limping. His right inguinal nodes were present. He was diagnosed as having cellulitis versus local immunization reaction. He was treated with Clindamycin. Follow-up on 7/31/01 indicated pt was much better.
Fever of 100.4; Chills, Shivering; A spontaneous report () was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever of 100.4, shivering.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events, chills. On 19 Feb 2021, the patient experienced the events fever of 100.4, shivering.  Treatment details included 2 Motrin.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, chills, fever of 100, 4, shivering was unknown.
Started swelling redness pain on Lt thigh on 6/8/2010 applied hydrocortisone 6/8/2010. 6/9 increased swelling, warm to touch, redness (14 cm x 15 cm size) to Lt thigh.
Menstrual cycle came 2 weeks early after receiving second COVID-19 vaccine injection. My cycle is very regular and it is extremely rare to have my cycle begin early.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dsoe 2 , single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Anti viral details included COVID 19 Treatment from 17Jan2023 to 21Jan2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large local reaction at site of Varicella and KINRIX vaccines, prescribed topical triamcinolone 0.1% and oral BENADRYL for swelling and itching (5 cm diameter area of swelling bilaterally).
Discharge Provider: MD Primary Care Provider: DO Admission Date: 9/9/2022 Discharge Date: 9/15/2022  Clinical Narrative: Patient is a 67 y.o. female who presented with malaise, body aches and chills for 10 days, with increasing SHOB as well as diarrhea/vomiting. She has PMH of rheumatoid arthritis on DMARD's, obstructive sleep apnea, former smoker, iron deficiency requiring transfusions, hypertension, GERD. She's been unable to eat x1 week and had developed a new cough the past few days.   Findings on admission included consolidated right upper lobe pneumonia with some evidence of necrosis in the lower aspect of the right upper lobe, as well as concern of obstruction of the right upper lobe bronchus.  COVID test was positive.  She had now on lung exam, although she did a formal diagnosis of chronic obstructive pulmonary disease prior to admission.  She was treated with IV Rocephin, doxycycline, IV dexamethasone, nebulizer treatments.  Antibiotics were subsequently changed to Zosyn.  Repeat imaging on 09/12/2022 showed no improvement in the x-ray and subsequent repeat CT imaging supported for complete obstruction of the right upper lobe with no endobronchial air, and increased changes of necrosis.   Patient was felt to require transfer to a higher level of care for pulmonary specialty care to include bronchoscopy, in addition to other potential interventions.  She was accepted at Hospital on Monday September 12, but a bed did not become available.  Subsequently a bed did become available at different Hospital on 09/15/2022.  Prior to discharge she did have a repeat chest x-ray which appears slightly worse including what appeared to me to be a small area of cavitation in the right upper lobe and some increase infiltrates evolving into the right lower lobe.  Her clinical condition however remained stable with a oxygen requirement of just 2 L.   Regards to chronic obstructive pulmonary disease, she had extensive wheezing throughout which improved prior to discharge with oral prednisone at 40 mg per day, combined with Symbicort, Spiriva, and albuterol inhaler 4 puffs q.i.d..  Her COVID-19 infection did not appear to meet criteria for treatment with remdesivir.  Due to a concomitant explanation for her respiratory symptoms, her isolation for COVID-19 was felt to be again on the date of the positive test on September 9, 2022.    The initial transfer on September 12, 2022 was discussed with Dr. who was to be the accepting physician.  However, with the change to different Hospital I spoke with Dr. from the hospital service accepted the patient transfer.  The case was also reviewed by Dr., a pulmonology who agreed with transfer.
Paralysis of left side of body including face. Hands and feet numbness and pain. Combination of peripheral neuropathy  and Gillian-barre syndrome.
My CD4 started going down and now it's in the 20% when it was above 33% for a whole.
no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 11 weeks old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 04-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U014992 was confirmed to be valid, expiration date: 29-OCT-2023) (dose, dose number, site and route of administration were not provided) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccine was improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005825: US-009507513-2204USA005826: US-009507513-2204USA005828: US-009507513-2204USA005829:
I had a flu clinic with company on 09-20-13. When I arrived at the site, I have the first shot for the employee. When I shot the second employee, the vaccine freeze. The pt bleed a little bit when I pull out the syringe after found out the vaccine freeze.
Generalized varicella rash.  Pt admitted to hospital 05/05/2013.  Treated with Acyclovir. Developed pneumonia and ARDs.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route unknown) (lot # H020255, expiry date: 08-NOV-2014), which was improperly stored vaccine. The outcome of the event was unknown. Additional information is not expected.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 29-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX 1 dose, subcutaneously in the right arm, lot # R002057, expiration date 22-JAN-2020. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.9 degrees Fahrenheit) for 45 minutes and the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (17.5 degrees Fahrenheit) for 13 hours. Data logger was involved. There were no previous excursions reported.
Rashes on left arm where the shot was received. Blisters forming and spreading on the arm and now on my back and left palm. Family physician provided antihistamine shot and recommended that I take zyrtec during the day and Benadryl during the night for the next 4 days.
I received my first dose of the Moderna vaccine on 12/28/2020. On 01/04/2021 night, I had a red lump on the injection site that was slightly itchy. The following day, the lump was still there, it was red and hot, but not painful. The redness had spread towards my chest but did not go past my armpit. The size of the lump has decreased since then, nearly gone today on 01/07/2021.
Immediately after the vaccine I got a week long migraine. The injection site was red, swollen and hot to the touch. 5 weeks after the vaccine I got a month long vertigo attack and started getting migraines and vestibular migraines. Migraines are now chronic lasting 21 days per month. Also brain fog, fatigue, visual aura, numbness in hands, neck/back pain.
After 24 hours felt tired, achy, arm hurt my head hurt for 48 hrs little longer. Upon waking up on Sat felt same symptoms. Due to patient exposure I contacted Covid hotline for that hospital employees. Then I was informed to go get tested ER for Covid results negative. I had to miss work on 12/21 due to taking Acetaminophen being a hospital criteria couldn't work while taking that medication.
No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant medications were provided.   On 13-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, vaccine scheme, dose number, route of administration and anatomical site of vaccination were not reported; lot number T030746 has been verified to be valid, expiration date reported and established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9F) during a time frame of 90 hours (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA003185:
pt had hives, chills, heaviness in chest & swollen lips; states was itching bad; laid down & took nap x 1 1/2 hrs; felt much better upon rising all sx were gone x/bumps on arm; advised to see MD;
Sides of tongue began to feel numb and tingling. Benadryl (25mg) taken at time of vaccination as recommended and again (25mg) 75 minutes later. Symptom subsided on Left side of tongue but continud on Right side of tongue. Numbness and tingling subsided about 3-4 hours after vaccination.
Systemic: Headache-Medium, Additional Details: Patient reported a headache tingling sharp pain in the back of her head. We asked her to wait for further observation. She said she was fine after 15 min and left
Had a 103 degree F fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a 103 degree F fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (Had a 103 degree F fever). At the time of the report, PYREXIA (Had a 103 degree F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, Body temperature: 103 (High) 103 degree Fahrenheit fever.         No concomitant products were reported.  No treatment information was reported by the reporter.
I have the two shots and still got it./ suspected vaccination failure; still got it; awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had 2 shingles vaccine, and still got shingles, it was awful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Hot, sore, red arm near injection site for 5 days so far, feverish for 2.5 days with malaise, loss of appetite, low energy.
The patient is a 67-year-old white male who presents to the emergency department with a chief complaint of abdominal pain.  He complains of pain in the left upper quadrant that has been present for the last 2 days.  The pain was initially intermittent but is now constant.  The pain radiates to the back on the left side.  Of note, the pain initially started as pain in the left mid back.  He denies exacerbating and relieving factors.  He admits to nausea and near emesis but no actual vomiting.  He denies diarrhea and bloody stools.  He denies dysuria and hematuria.  He has no history of kidney stones.  He denies chest pain and difficulty breathing.
11/12 Raised, itchy raised rash 11/13 Blisters developed, itchy & worsened 11/14 Red Blistered
acute ischemic stroke; nausea/emesis; nausea/emesis; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around 26-SEP-2017, pt was inoculated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered an abrupt onset of vertigo, vision loss and nausea/emesis. Pt was hospitalized and diagnosed with an acute ischemic stroke. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, acute ischemic stroke was determined to be medically significant. All events considered as disability by the reporter.
By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.; felt really sick; I was in misery; headaches; joint pain; fever; chills; throw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills) and VOMITING (throw up). On 22-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.). At the time of the report, ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), VOMITING (throw up) and ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.) outcome was unknown.            No concomitant medications were reported. Patient went for vaccination on 22-Sep-2022. Instead of receiving Moderna Covid-19 vaccine and a flu shot there was medication error and got two Moderna Covid-19 vaccine on each arm. Patient felt like 24 hours in misery. No treatment information was reported.
Pt recv vax on 1/13/99; on 1/15/99 pt exp hives over body/ head, fussy, spitting up; dx=allergic rxn to Similac w/ iron formula tx=Benadryl, triamcinolone, switched pt to soy formula
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/29/20 PfizerLot#EL0142 2nd dose: 01/19/21,Pfizer,Lot# EL3247 Diagnosed covid positive:07/28/21 Symptom onset: Exposure:Travel Symptoms:
Her arm was very swollen and hard. When I went to take off band-aid some skin came off. (Sunday 11/13/05). This morning her arm had not changed in size but it was hot then later swelling spread and it was reddish color (11/14/05) 9".
Tinnitus started three weeks after shot. Primary care doctor and audiologist do not know cause.
A little weak; Arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 26Feb2021 (Lot number: EN6200) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vertigo" (unspecified if ongoing), notes: at least 15 to 20 years ago; "Meniere's ear" (unspecified if ongoing), notes: at least 15 to 20 years ago; "endolymphatic shunt" (unspecified if ongoing), notes: at least 20 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Feb2021, outcome "recovered" (02Mar2021), described as "Arm was sore"; ASTHENIA (non-serious) with onset 01Mar2021, outcome "recovered" (02Mar2021), described as "A little weak". Additional information: Vaccination time was reported as around 02:45 PM to 03:00 PM.  No follow-up attempts are possible. No further information is expected.
Post Menopausal Bleeding - have now had two consecutive menstrual Period. I am three years post menopause. This is highly unusual and all other potential causes have been ruled out
My periods, starting in February 2022,  have been heavier, longer, and start earlier than prior to receiving my second dose of the vaccine. On average, periods now last two weeks since February 2022. My last period lasted 15 days, and I began my most recent period only 8 days after my previous one ended. I have not stopped bleeding profusely since January 28, and have decided to seek medical treatment once I'm able to reach my PCP on Monday, February 6, 2023, as I have been bleeding through tampons within an hour, and woke up February 3 and 4 in a pool of blood, after soaking through both a tampon, overnight pad, and the undergarments and joggers I wore to bed. I have never experienced menstrual bleeding to this extent and feel weak and lightheaded.
The same day at night I had a fever and chills. The next day the fever and chills continued. In addition, a week after the vaccine was administered I had severe pain in the ovaries area and my menstruation was 19 days earlier, which had not happened to me due to having a regular cycle.