chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a big red spot all around to her arm; normal red spots where the Band-Aid was, then it got bigger, it got like 2 inches, then 4 inches, then 6 inches, had a huge bright red spot that went all the way around her arm; itching; arm is sore; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient's family history included: "Pneumonia" (unspecified if ongoing), notes: so many family members that have died from Pneumonia. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Jan2023, outcome "recovered" (Jan2023), described as "arm is sore"; PRURITUS (non-serious) with onset 27Jan2023, outcome "not recovered", described as "itching"; ERYTHEMA (non-serious) with onset 28Jan2023, outcome "recovering", described as "normal red spots where the Band-Aid was, then it got bigger, it got like 2 inches, then 4 inches, then 6 inches, had a huge bright red spot that went all the way around her arm"; MACULE (non-serious), outcome "unknown", described as "had a big red spot all around to her arm".  Therapeutic measures were taken as a result of pruritus.  Additional information: How long before her arm stops itching? She got the Prevnar 20 vaccine on 27Jan2023, and normally her arm is sore for a little while, which even happened with the covid vaccines. She had a normal red spot where the adhesive of the Band-Aid touched her skin, but then the red spots got bigger. The red spots got to be like 2 inches, then 4 inches, then 6 inches; she had a huge bright red spot that went almost all the way around her arm. States that she was fine with that and the redness has faded, but it still itches. This reaction to the Prevnar 20 is not life threatening; it's just annoying, her any kind of shot, her arm will hurt. The arm soreness after receiving the Prevnar 20 was gone by Sunday, 29Jan2023 or Monday, 30Jan2023. The itching on her arm might be slightly better, but is pretty much the same. She has been using anti itch creams to calm down the itching.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
AFTER RECEIVING 2ND SHOT OF GARDASIL 4/12/07  SHE DEVELOPED A RASH ON THE INSIDE OF HER ARM(SAME AREN BUT OPPOSITE THE SITE OF THE INJECTION)- SHE HAD NO OTHER SIGNS SYMPTOMS- THE RASH WAS MACULOPAPULAR AND THE AREA INVOLVED WAS 4 CM IN DIAMETER
Red, circular blotch on skin near injection site  warm to touch with slight discomfort when touching
Got earache on 6/11/2022. Called provider in the middle of the night, Dr. called me back and gave me a prescription for ear drops. Next morning, started getting sniffles and was coughing and had fever. Home test came back positive. Called my Dr. and had a Telemedicine appointment. Dr. prescribed Paxlovid on 06/13/2022. Breakthrough case.
Partial dose administered. When removing the Magellan syringe, vaccine leaked out. When injecting and depressing plunger, the needle loosened from syringe and almost the entire dose leaked out. Patient re-vaccinated.
She started with soreness in right arm.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (She started with soreness in right arm.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SIMVASTATIN and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (She started with soreness in right arm.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (She started with soreness in right arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medication also included Muscle spasm and acid reflux medicine.  Treatment medication also included rubbing alcohol.
Day after SHINGRIX, on left arm, start to show redness and felt the heat around the redness. Per patient, is it non-itchy rash, no difficulty of breathing or swallowing. Recommend ZYRTEC and if symptom get worse call MD or urgent care.
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 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Fluoroquinolones, reaction(s): "Known allergies: Fluoroquinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for two days; Positive, notes: I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used as treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10 min after injection became dizzy.   BP 130/102, HR 105/107 SPO2 99%, T 97.7 Started taking Zoloft 50 mg QD 1.5 weeks ago  Had COVID in Nov 2020 BP recheck 146/88, HR 98, Dizziness resolved @10:50AM
This spontaneous prospective pregnancy report was received from a registered nurse, referring to a 31 year old pregnant female patient. Neither pertinent medical history nor concomitant medications were reported and patient presented no known drug allergies. On 07-JUN-2016, the patient who was 30 weeks and 4 days pregnant, came to the office to be administered with t-dap vaccine, and was inadvertently given GARDASIL lot # K006191 with expiry date on 02-FEB-2017, intramuscular. The primary reporter states it was the patient's first baby and pregnancy. No adverse effects were reported. The patient became pregnant with last menstrual period (LMP) of 09-NOV-2015 and estimated delivery date (EDD) of 15-AUG-2016. Initial exposure to GARDASIL was at 30 weeks. The patient did not seek medical attention, no lab diagnostics studies were performed and no treatment was received. No product quality complaint was reported. Additional information has been requested.
DIZZINESS/NAUSEA, ADVISED TO LAY SUPINE, LAST MEAL 7AM, PROVIDED WATER/SNACK. SX RESOLVED. NO TRANSPORT.
developed pneumonia 12 days ago; This is a spontaneous report from a contactable consumer (patient).  This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Jun2021 (12 days ago, as reported), the patient developed pneumonia for which he took antibiotics. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Tingling starting at sight slowly traveling down arm reaching fingertips at about 1.5 hrs post shot. Took liquid benedryl at about 1.25 hrs post  shot and around 1 1/2 hrs post shot started to experience mouth/tongue weird sensation. Post benedryl around 2 hrs mouth symptoms started to retreat.
I went to my doctor today. He told me she hit either a nerve, ligament or bursa when she gave me the injection. He thinks most likely a ligament or bursa since the pain when she gave me the injection did not travel down my arm. He gave me a prescription for steroids to reduce the inflammation and wants me to ICE it regularly. Once the inflammation goes down I will need to do exercises to get the range of motion back. I have a follow-up appointment on Monday so he can check if any improvement from steroids.
28NOV95 shot given @ 745AM felt dizzy & hot by 11AM;ate lunch was extremely hot & felt faint @ 12:30;felt fine @ 830PM;was sore where shot was given
No additional AEs; Vaccine was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 11-APR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # W004694, expiration date: 08-AUG-2023) 1 time dose for prophylaxis (strength and route of administration were not reported) after temperature excursion that the vaccine had been stored at -13.7 degrees Celsius for 19 hours (product storage error). There was a previous temperature excursion which was reported as 8.2 degrees Celsius for 21 hours and 51 minutes. No additional adverse events (AEs) or product quality complaints (PQCs) were reported.
PATIENT DESCRIBES INJECTION SITE NUMBNESS AFTER VACCINE THAT GRADUALLY SPREAD DOWN ARM. PATIENT STATES THAT THE NUMBNESS COMES AND GOES, AND IT ALTERED HER DAILY LIFE ENOUGH TO SEEK TREATMENT WITH CHIROPRACTIC THERAPY. THE NUMBNESS CAN CAUSE PATIENT TO LOSE GRIP OF ITEMS IN HAND, AND PREVENT PATIENT FROM USING HER HAND APPROPRIATELY
Mother states child has had decreased response to verbal stimuli, poor balance with increased falling, decreased urine output and decreased appetite since 1-2 days after vaccination.  Temperature varies from 99-101.  On 10--7-2008 red raised rash noted on outer thighs, back and ankles.  Recommended that child be seen by physician.  Mother states she will scheduled appointment.
Immediate bruise then to red hot swollen mark about the size of a baseball.   Aches chills fever malaise migraine headache    Still achy headache today 9/3 with red tender soar arm
Heart palpitations, irregular heartbeat, chest/shoulder tightness and pain, appendicitis
Given FLUZONE HD 2014-2015 (49281039565) then shoulder bright red ellipse (4x8 inches), weakness/exhaustion for 4 to 12 days afterwards.  Sudden onset dizziness/near fainting on 09/20 or 12 days later, which is very similar to incident back in 1986 after 2 weeks after having the flu then (which then caused a horrible auto accident).  Many women in 1986 had fainting from the flu. We conclude that patient should never take the High Dose; her late physician only gave her a "half dose."  The pharmacy person said everyone over 65 was supposed to get the High Dose.  This should not be recommended so broadly.  I had the HD with no ill effects.---husband (age 71).  If she had fainted at the wheel, this would be a Life Threatening Illness!
Rec'd immunization for about 1130 AM. At about 1600 pm had rash all over body and fever up to 102 degrees. At about 1600 vomited large amount. Rash continued until current time of 9/29/10 at 1400.
pt recvd vax; recvd WB exam 14sep94; mom found baby dead in early am; cold slept on stomack in play pen;
Information has been received on 18-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other related complications. On or about 17-DEC-2014, the patient was treated by a physician's assistant at a medical group for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 30-APR-2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 04-OCT-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
I had gotten the vaccine on Wednesday night at 7 pm and felt fine until the next morning when I woke to my whole body feeling like the ache in my arm. Around 9 am I developed rapid symptoms of the flu; chills, fatigue, nausea and my body felt hot (but I didn't have a temp). This lasted for about 3 hours of feeling pretty bad and then out of the blue, I felt fine again. Later in the afternoon around 4pm the symptoms came back but not as bad and lasted until I went to bed. I didn't take Tylenol because I read that it was better for your immune system not to take it if you can.
Severe right arm pain especially at injection site, dizzy, nausea, vomiting, fever, severe headache, chills, shaking, photophobia, phonophobia, neck pain, low back pain.
pt was given varciella on 1/24/23when MMR was given on 1/9/23. pt was notified.
patient  had already received the bivalent  vaccine  once  on 09/12/2022 from another pharmacy and  miscommunication lead to us giving another  dose  of the bivalent  vaccine. patient was/is  stable and  have not reported any side effects or adverse reactions
5 hours after injection in left deltoid, my arm was was in pain/sore but just at injection site. Day 2 my  arm was  still  in pain .  Day 3  pain  was gone and  I felt ok.  At day  8  injection site is  itchy/ tender and I now have a welt.  Day  9  itching  is gone but now  I have a  welt  and  injection site is red and  hot to touch.
Phone call from patient' s 2 daughters on 3/10/2021.  Patient was found dead in bed with a remote in his hand.  He had not been sick.  He had received Moderna SARS vaccine 2/27/2021= 11 days earlier, but did not have any adverse reactions.  He had recovered from lumbar spine surgery several months earlier.  He was pronounced dead by the fire chief.
2 days, post vax, noted at left anterior thigh a 5mm area of redness and induration without warmth. Also, with faint light red petechial rash distal to puncture site to level of knee only involving anterior aspect of thigh. No associated perfusion problems or generalized edema of this lower extremity.
Tightening in her right calf; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6202) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 26Feb2021, outcome "recovered" (2021), described as "Tightening in her right calf"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "sore arm". The event "tightening in her right calf" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (2021) heart palpitations; electrocardiogram: (2021) abnormal; magnetic resonance imaging: (2021) heart palpitations; pulmonary function test: (2021) unknown results; x-ray: (Oct2021) unknown results, notes: pulmonary. Therapeutic measures were not taken as a result of muscle tightness, pain in extremity. Therapeutic measures were not taken as a result of muscle tightness, pain in extremity. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 03-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Large red ring encircling entire upper arm.  Inner red ring more red than outer ring, 4 large yellow fluid filled blisters nearest the needle insertion site.  Arm is hot, firm to the touch, painful, itchy.  Fever x 2 days, body aches, diminished appetite.
Patient developed bloody diarrhea and NBNB vomiting later in the day after receiving his rotavirus vaccination. Patient was brought to the ED 2 days after vaccination as his symptoms were not improving. Abdominal ultrasound demonstrated small bowel on small bowel intussusception. Patient was admitted to the general pediatrics service of the hospital and treated with IV fluids and acetaminophen for supportive care. Viral PCR came back negative for common viral causes of enterocolitis but positive for Rotavirus. At this time, bacterial cultures are still pending and the patient will remain in supportive care in the hospital.
3-4in red indurated area @ site of inject w/in 1 hr; temp 103 for several hrs; 1 bout of vomiting; very irritable w/prolonged crying; rx APAP, DImetapp, cool compress to site;
On 31JAN92 2nd DTP recvd per mom of Pts hx-had t104.6 x 2 days & was extremely fussy; pt did not call a MD @ that time; states used APAP;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 03-SEP-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # G007459, expiry: 02-AUG-2013. No adverse effect reported.  Additional information has been requested.
Couple days after receiving flu vaccine developed flu like symptoms and fatigue. 10/4/17- developed rash on back/itchy and had tingling/burning sensation to hands and feet. 10/10/17- developed tachycardia. Went to ED and lumbar puncture and labs performed. Overall symptoms: sensory: numbness, paresthesia, burning sensation hands/feet, decrease sensation in foot. Autonomic: heart burst, sweating, palpitations, difficulty speaking in sentences, poor voice quality and weakness. Was admitted to hospital from 10/20/2017-10/23/2017 for management of variant of Guillain-Barre Syndrome (likely sensory and autonomic variant), following flu shot.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tender to the touch) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MALAISE (Feeling sick), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tender to the touch). At the time of the report, MALAISE (Feeling sick), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tender to the touch) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were provided by reporter.
Started fever on Wednesday, 6/12/01 at night. Fever of 103.5F, was the highest. No appetite and fussy. Was seen in doctor's office on 6/18/01.