chrisvoncsefalvay/vaers-outcomes huggingface dataset:
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant drugs were reported. no treatment drugs were reported.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. On or about 17-MAY-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a nurse for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Client presented at vaccination site on 01.13.22. Client reported she received first dose of Moderna COVID vaccine on 03/23/21 (lot #: 008B21A) with no issues. Client reported she received second dose of Moderna COVID vaccine on 04/24/21 (lot #: 014C21A), she stated within 10 minutes after the shot, she had dizziness, lightheadedness, weakness, and shortness of breath (breathing hard and feeling like she was going to faint but didn?t faint). Client reported the MD at the vaccination site took her BP and told her BP was low and she was experiencing a panic attack. Client denied any history of panic attacks or anxiety. She stated she didn?t follow-up with her PCP. She reported she didn?t have any chronic illnesses, not on any medications, or have any known allergy. Client reports she takes iron pills when she gets her period as needed. Client reports she has a fear of blood draw and injection. Today, PHN took client?s vitals: BP 129/93, HR 93, O2 Sat. 100 %. Client is requesting for the booster dose of Moderna COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the booster dose of Moderna COVID vaccine. Per the doctor, approval to proceed with the booster dose of Moderna COVID vaccine was obtained via text message from clinical project coordinator. Client received the booster dose of Moderna COVID vaccine, LOT#: 084J21A on 01/13/22 at 1509 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1539 unassisted and with a steady gait.
pt recv vax 2MAY96 & had a bad couple of days all the way around for many reasons;
pt recv vax 11AUG97 & was sleeping & suddenly shook, eyes rolled back, mouth came open & became limp x few sec;not breathing & looked lifeless;T102 R;pt less active & sleepier than nl;MD felt probable illness,viral poss feb sz;
New redness and swelling at injection site 10 days post vaccine. Mild radiating pain and warmth.
Tenderness at injection site; Bulls eye rash at injection site; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness at injection site/vaccination site pain, bulls eye rash at injection site/vaccination site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 3 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the events, tenderness at injection site, bulls eye rash at injection site.  No treatment details were reported.  The patient received both the doses of mRNA-1273  prior to the events, therefore action taken against the drug in response to the events was not applicable.  The outcome of events, tenderness at injection site, bulls eye rash at injection site was unknown.
Headache, Myalgia, Arthralgia, Fever, Rash,  NauseaVomiting, Nausea, fatigue, sore throat, tongue edema, fever, rash
Patient was given vaccines in office on 8/23/18. He was then seen in Urgent Care on 8/29/18 for right eye edema and hives and swelling noted to bilateral cheeks, feet, legs and arms. Nasal congestion and discharge also present on exam in urgent care. Oral benadryl and IM Epinephrine given in urgent care for worsening hives. Sent home with Benadryl prescription to be used every 6-8 hours PRN.
outbreak / on neck, chest, shoulders and back; Shingles on face/Shingles rash; Varicella-like; This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   On 2nd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than 2 weeks after receiving Shingrix and an unknown time after starting acyclovir and Valacyclovir, the patient experienced rash, shingles and varicella-like rash. The patient was treated with acyclovir and valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the rash, shingles and varicella-like rash were unknown.   It was unknown if the reporter considered the rash, shingles and varicella-like rash to be related to Shingrix  Additional details were provided as follows The patient experienced an outbreak of Shingles then went to physician and the outbreak started on face then traveled down the neck.  On 13th March 2020, the patient experienced another breakout on neck, chest, shoulders and back. On 13th March 2020, the patient's physician started Acyclovir 1 gram three times a day which she took for about 2 weeks. On 5th May 2020, her 2nd outbreak was started. The patient used Valacyclovir 500mg that she had from the past. The blisters were no blisters, looks like chicken pox rash. The reporter did not consent to follow up.
Left arm was mildly sore, as expected. Around 10 pm Thursday, I started feeling chills. During the night I felt fevers and chills alternating. Around 3  am, I was nauseous and vomited, although there wasn't much actual vomit. I vomited again around 9 am the next morning, with even less vomit, since I hadn't eaten any breakfast. I rested most of Friday and ate sparingly. Today (Saturday) I feel better.
Local erythema, pain, edema which resolved 2-3 days. The parent applied anti-itch otc med.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of GARDASIL (lot # not reported) that were exposed to 33.6 F for 1 hour. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Severe Itch  migrating all over body for several hours  that culminated in Urticaria, diarrhea, loss of consciousness, nausea. Nausea persisted for 2 days. Urticaria /itch has been reducing dramatically  over time but still persistent at 6 weeks since onset of symptoms. Treatments tried include-  antihistamines. A course of steroids. Now on Zyrtec.
Diarrhea/cramps  x 1 day, followed by chills & muscle aches 2 days, followed by diarrhea 1.5 days.
Severe chills, fever starting around midnight until 4am on 4/2/2021. Back pain, shoulder joint pain and neck pain. Shoulder and neck pain still persist as of 4/21/21. Headaches persist. Monthly cycle was 7 days late.
Stroke, left side of brain on 2/28/23.  Carotid Enarterectomy, left side on 3/3/2023.
Initial report was received from a health care professional on 15 Dec 2009: This patient (17 month old child) inadvertently received FLUVIRIN 0.25 ml, dose intramuscular on an unknown date. No adverse event was reported.
After sitting for 5 minutes post vacc. injection, left gym, felt dizzy then returned to gym and fainted, face first with LOC x 10 seconds. Initially disoriented, then AAO x 1 hour post fainting spell. BP 90/50, 100/50. Pulse 80-88, disphoric. Rest, observed.
Low grade fever 99-100 degrees F. Some dizziness after injection. Took TYLENOL for fever. Soreness at injection site.
had seen TV program suggesting poss problems from flu shots so nervous-10 mins p/shot felt lightheaded, tight in chest & fell backward, striking head on glass shelf then tonic-clonic movements, irreg gurgling respirations, unresponsive;
Malaise; joint pain; pain in the arm; fever; feeling horrible; flu-like symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced side effects like malaise, joint pain, pain in the arm, fever, feeling horrible and flu-like symptoms. Outcome of events was unknown.  Information on Lot/Batch number has been requested.
Approximately 24 hours after first Moderna vaccination,  malaise, slight headache, generally feeling unwell.  Took 1 baby aspirin.  Symptoms lasted 8-12 hours and resolved after good night's sleep.
The patient is experiencing soreness/achiness in vaccine arm. Reports that it started on 10/20/2023 after vaccination and is ongoing. The patient described it as an ache that starts at the site of injection and runs down his arm. He reports heating pads help relieve the pain.
Treatment of COVID-19; Treatment of COVID-19; Pfizer-Dose Number: 3; Moderna- Dose Number: 4; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 301553A) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13May2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing); "Known allergies: raw almonds" (unspecified if ongoing); "Known allergies: avocados" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12May2022, outcome "unknown", described as "Pfizer-Dose Number: 3; Moderna- Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment start date: 10Feb2023, treatment stop date: 15Feb2023.   No follow-up attempts are possible. No further information is expected.
Immunizations given 2/14/08.  2/16 - patient developed 'red spots'.  2/17 - rash itchy, child edematous, taken to hospital.  Diagnosed with hives, given Benadryl.
Information has been received from a nurse practitioner concerning a 20 year old female who in August 2007, was vaccinated with her first dose of GARDASIL and she received her second dose of GARDASIL in December 2007 at another office. Subsequently, the patient commented the second dose was more painful than the first. No specifics known as given at another practice. The patient sought medical attention at office. Additional information has been requested.
Small red papules appeard on legs that pm.  Seen in office on 11-23-09 due to increase in size of bumps and more noted to legs.  Rt. anterior leg half dollar size, oval, tender to touch, no discharge, no adenopathy.  Smaller red papules on lt. lateral thigh, smaller papules on rt. leg noted. Diagnosed with Erythema Nodosum.
Within one hour after influenza shot pt had itching head. By that night itching head to toe. Hives developed with itching. Became flushed, bright red, left arm had swollen area at injection site, bright red, warm to touch, Treated with Benadryl, Medrol pack
Developed a ringing in my right ear. Never had tinnitus before so this was very new. Its now going on day 6 with ringing in my ear. Cause me to lose sleep.
A nurse reported that a pt received an injection of Prevnar and subsequently, developed cellulitis at the injection site. No further information was available at the date of this report. The reporter indicated that 13 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Rash lasted 3 days; less than 12 pox. No fever, no complications, no meds received.
The physician who put the order in for Gardasil 9, is no longer at the clinic. They physician ordered it as part of a "routine" vaccination.; In Nov/Dec of 2018, a nurse administered GARDASIL 9 to a 6-month old infant male.; This spontaneous report was received from a registered nurse via company representative, concerning to a 6-months-old male patient. The patient's pertinent medical history, previously drugs reactions or allergies and concomitant therapies were unknown by the reporter.   On an unspecified date in 2018 (reported as November or December 2018), the infant was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), in the thigh; the physician ordered it as part of a routine vaccination (formulation, strength, dose, dose number, lot number, and expiration date were unknown by the reporter). The physician who put the order in for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), was no longer at the clinic. Additional information about the event was unknown by the reporter.
Information has been received on 31-AUG-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 01-JAN-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUL-2014, the patient was treated at a physician's office, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
RECEIVED THE SECOND DOSE AROUND 5 PM, STARTED HAVING HIVES APPROX 3 HOURS AFTER THE INJECTION.  I TOOK BENADRYL, PEPCID, AND XYZAL TO TRY TO GET RID OF THEM.  NOT ONLY DID THEY NOT IMPROVE, BUT WORSENED SIGNIFICANTLY, COVERING MY ENTIRE BODY.  I MADE AN APPOINTMENT TO BE SEEN IN A CLINIC, AND WAS GIVEN A STEROID INJECTION, FOLLOWED BY ORAL STEROIDS, AND WAS GIVEN A STEROID CREAM.  IT TOOK OVER 48 HOURS FOR THE HIVES TO RESOLVE.
Infant developed afebrile seizure approximately 10-12 hrs after receiving the DTap, Comvax, and Prevnar.
Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nausea. Severe headache. Severe coughing with some sputum.
flushing;rapid pulse 110-thready;lightheaded;sl disorientation;evaluated @ ER given DPH;
51 year old female with chief complaint of dizziness.  Approximately 10 minutes post vaccine administration, patient stood up in and approached the observation staff.  The patient was asked if she was okay and did not respond but grabbed the table to stop herself from falling.  The patient was immediately assisted to the gurney in and placed in a supine position.  Vital signs obtained and initial vitals signs stable.  Patients legs elevated.  Patient was A&O x 4 but was slow to respond to questions.  The patient complained of dizziness and denied any other complaint.  The patient never lost consciousness and there was no traumatic event.   Patients second set of vitals signs demonstrated a decrease in blood pressure and paramedics were contacted.  Patient had a molar extraction by her dentist x1 week ago and denied any other medical history.  Allergies to PCN and only medication is Advil/Ibuprofen for tooth extraction.  Patients husband confirmed medical history and information.  Patient had equal grips/pushes with no facial droop, arm drift or slurred speech.  Paramedics arrived, received report and took over patient care.  Paramedics placed patient on cardiac monitor showing a normal sinus rhythm.  Blood glucose normal with pupils equal and reactive to light.  3rd set of vitals signs returned to normal and patient stated that she had a significant decrease in symptoms.  EMS explained risks and consequences patient but denied further evaluation, treatment or transport with EMS.  The patient was wheeled to private vehicle and was transported by husband home.
Heart rate accelerated; Chest began to hurt; It feels like intense pressure in my chest. As if someone is sitting in it.; Along with body aches; Immediately the site of injection was burning.; This is a spontaneous report from a contactable consumer. This 51-years-old non pregnant female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in arm left on 25Mar2021 11:00 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Age at vaccination was 51 years. The patient medical history and concomitant medications were not reported. On 25Mar2021 11:00 the patient experienced immediately the site of injection was burning, heart rate accelerated, chest began to hurt, it feels like intense pressure in my chest as if someone is sitting in it, along with body aches. Patient reported immediately the site of injection was burning. After 5 minutes her heart rate accelerated, and her chest began to hurt. It feels like intense pressure in her chest. As if someone is sitting in it. It has been almost 5 hours and she is still feeling intense chest pressure along with body aches. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
From initial information received on 05/27/03 from a health care professional regarding an adverse event occurring in the US, it was reported that a 30 year old female pt received a dose of TD ADS /ADULT, Lot # U0831AA, given IM in the right arm on the evening of 05/20/03.  On 05/07/03, seven days later, the pt developed a red, painful, swollen area at the injection site with clear discharge. Reportedly, the recovery status is unknown. From additional information received on 01/07/04 from health care professional, the pt's address and the responsible physician's name were provided.  The reporter of this case is the same reporter for case: 2003-01030.
Shingles- I had shingles that presented on my V 1 nerve; This is a spontaneous report from a contactable consumer. A 36-year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot number: EL9267 and Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on Feb2021 as DOSE 2, SINGLE (age at vaccination 36-year-old) for covid-19 immunisation. The patient medical was none. There were no concomitant medications. No patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and No other medications the patient had received within 2 weeks of vaccination. The patient historical vaccine includes received BNT162B2 (BNT162B2, PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot number: EL9263 and Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on Feb2021 at 2.00 PM as DOSE 1, SINGLE (age at vaccination 35-year-old) for covid-19 immunisation. Prior to vaccination, was the patient diagnosed with COVID-19 was No. Since the vaccination, has the patient been tested for COVID-19 was No. It was reported that she had shingles that presented on her V1 nerve on 21May2021. The events resulted in emergency and physician office visit. Therapeutic measures were taken as a result of shingles included Valtrex and Gabapentin. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
she received her 2nd Moderna vaccine 5/5/21 at a pharmacy. she presented to my clinic on 5/7/21 with complaints of left sided upper body swelling/itching (including her face, which had improved by time of presentation) and left arm soreness. she had visible erythema, swelling, and tenderness of upper left arm but no other physical exam abnormalities at the time of my evaluation on 5/7/21.
Patient Felt dizzy after leaving Pharmacy. He fell in the Aisle but did not hit his head. We had him Lay There for 5 minutes and Then he sat in a chair for 15 minutes and Then he requested to Leave
Patient received initial dose from our facility. On date noted received a call from the local Health Department saying they were going to administer the Pfizer pediatric dose but the patient's card said they had received an adult dose from us. After further questioning, it was determined that patient's father had lied about his age when they received the first dose. The actual birth date was 08-18-2011. Local health dept. confiscated the first Covid card. At this time we cannot determine if the pediatric dose was given.