chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report of feeling of itchiness in throat and face approximately 20 min post vaccination. Pt. VS performed and stable. Pt. administered therapeutic injection per PCM orders: Diphenhydramine 50 mg IM, DEPO MEDROL 120 mg IM and ZANTAC 150 mg PO. Pt. monitored for 20 min post therapeutic injection and medications. Remained in stable condition. Pt. reported symptoms subsided and witnessed leaving clinic with mother with no symptoms remaining.
Immediately after vaccination, the upper left arm had a small welt and the arm and shoulder.was very painful--she was unable to lift her arm. The next day, she was quite ill; she was extremely fatigued and slept  20 hours. The following day the symptoms disappeared. A week later the site of the vaccination became hot and a welt began to form. A day later, the welt expanded and is continuing to expand and is currently 3 inches in diameter. She is experiencing fatigue additionally. *Please note that her menses have begun 2 weeks before it should.
RUE rash at site of inoculation 7x3 cm erythematous area fading into normal tissue, tender to palpation (Pt also experienced headache, bodyaches, fever, fatigue)
Pt w/ hx of allergy to penicillins - swelling that required hospitalization.  Pt presents w/ facial rash/hives, dizziness.  p/t c/o tingling/numbness BLA LE, RUE.  BP 164/92, HR 116, RR 16 -- > 160/94, 116, 16.  911 called and the patient was taken to the Emergency Room ~30mins post vaccination.
Swelling, mild induration at site at injection noted on exam 24 hrs later. No systemic sx.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-JUL-2016 the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 27 years and 6 months.  No concomitant medication information was provided.  It was reported that medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. No patient had any adverse reactions and there were no reports of any reactions after the administration of vaccines.    Moderna vaccine Ndc code reported as 80777-0273-99.   No treatment information was provided.
This case was reported by a other health professional via call center representative and described the occurrence of injection site infection in a 57-year-old female patient who received FLULAVAL QUADRIVALENT (batch number XZ3SP, expiry date June 2015). Previously administered products included flu vaccination with an associated reaction of scar. On 4th November 2014 at 10:30, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In 2014, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site blisters. On 4th November 2014, the patient experienced injection site pain and injection site erythema. In November 2014, the patient experienced injection site infection (serious criteria GSK medically significant). In November 2014, the outcome of the injection site pain and injection site erythema were recovered/resolved. On an unknown date, the outcome of the injection site infection and injection site blisters were recovering/resolving. It was unknown if the reporter considered the injection site infection, injection site blisters, injection site pain and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional information received: This patient experienced injection site redness and soreness immediately after receiving the vaccination. She then noticed that a small pimple formed at the injection site but could not confirm when it first occurred. But now the pimple has developed into a blister about the size of an eraser. The blister had to be lanced and drained today and the physician believes it is an infection and not a reaction to the vaccine. The reporter believes that this infection was most likely caused by a flaw in their administration technique.
Information has been received from a nurse, via a company representative concerning a 13 year old female patient, who in August 2007 (during the week of 13-AUG-2007), was vaccinated with the first dose of Gardasil (lot # not provided), and was also vaccinated with a dose of MENACTRA.  About 2 to 3 minutes after the vaccination was administered, the patient "passed out."  The nurse indicated she was out for approximately 20 to 30 minutes.  She was given a drink and had a cloth on her head, and was feeling better.  No medical treatment was required.  Additional information has been requested. Follow up information from the nurse stated that there were no further incidents or reactions reported. Additional information is not expected.
On day 6 after getting the vaccine I have developed Covid Arm with considerable swelling, hardness, a red rash and extremely itchy.
Severe muscle pain all over body with fever, unable to function. Now has lasted fro one week and still continuing
May 2- Urgent Care. Presents today with a shooting pain behind the left ear that radiates down her neck since 0200 today. June 12- ER. Outcome: Diagnosed with Epicardial Fat Necrosis. Presenting with sudden onset, sharp left-sided chest pain radiating to the left shoulder since 1100. Pain rated 9/10. Pain improved by leaning forward.  Pain is worse lying supine.  Pain is worse with deep inspiration. Tried ibuprofen and Tylenol with minimal symptomatic improvement.  No history of similar symptoms. Patient's presentation consistent with epicardial fat necrosis given increased attenuation of pericardial fat on CT, trace pleural effusion, and left-sided pleuritic chest pain worse with postural changes. Pericarditis considered given postural component of patient's symptoms EKG without evidence of pericarditis, ACS unlikely given no ischemic changes on EKG and negative troponin.  Pulmonary embolism considered given sinus tachycardia, pleuritic chest pain, and mildly elevated D-dimer, but unlikely given no clinical signs of DVT, dyspnea, or pulmonary embolism on CT.   6/13 ER This is a 25 year old patient who presents with chest pain.    Considered the possibility of pericarditis given patient's pleuritic and positional chest pain.  However, her EKG continues to show no signs of such.  Patient's troponin is not elevated making myocarditis less likely. Dissection were considered but felt to be extremely unlikely given overall presentation and imaging deferred.  PE highly unlikely given negative CT PE study yesterday.  No vomiting to suggest esophageal perforation.  No cancer history to suggest pericardial effusion.  History and exam not suggestive of pneumonia or pneumothorax.    Suspect patient's symptoms are due to the epicardial fat necrosis seen on previous CT chest.  Patient was treated with 15 mg of ketorolac with minimal improvement and pain.  She was then given 10 mg p.o. oxycodone, 1 g acetaminophen, a L of IV fluid and ondansetron with some improvement in symptoms.  Patient was discharged home with a prescription for oxycodone and ondansetron. Patient was provided with return precautions prior to discharge.  Impression:  Chest pain, epicardial fat necrosis
a patient was administered Menactra that had expired /no AE; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Medical Information (MI) (Reference number- 00829553).  This case involves a 13-year-old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that had expired (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE, HPV VACCINE VLP RL1 9V (YEAST), and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Prophylactic vaccination.  On 26-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6691AA and expiry date: 21-Oct-2021) via an unknown route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Nurse is looking for information that they should inform to the patient, as well as if they need to re-vaccinate."  At the time of reporting, 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.
Hives all over her body; The following information was received from a pharmacist on 15 Jan 2019.  A 34 year old female received her first dose of IXIARO (Japanese encephalitis vaccine, batch number JEV17M64E) on 11 Jan 2019.  Two days later (13 Jan 2019) she experienced hives all over her body. Under treatment with Benadryl the event did not resolve.
Patient states: itching/rash on left arm started 5-31-18 at night (estimated time reported as 10 PM). Self treated with BENADRYL. Patient comes to ER on 6-3-18 at 11:08 AM with complaint of cough with mucus and swelling which started that morning (on 6-3-18). Patient denies: swallowing difficulty, breathing, fevers, chills, palpitations or nausea and vomiting. Treatment: Methylprednisolone 125 mg once, diphenhydramine 25 mg once, famotidine 20 mg once.
local erythema, swelling, fluctuance, induration, occurring within hours of vaccine administration and lasting over two weeks since
21MAR 3Pm mom called reports rash around pt's mouth, eyes swollen, no resp distress, but pt did not limp;
Vaccine error, they gave patient a 3rd dose of Hep A, when it was on her chart and not needed. I am not sure of the Hep A type that was given.
This spontaneous report was received from a medical assistant concerning to multiple unspecified patients of unknown age and gender. The patients had no pertinent medical history, concurrent conditions and concomitant therapies. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot number L048854, expiration date 31-AUG-2017, orally (dose number was not provided). No adverse events were reported. There was not product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Throwing up; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VOMITING (Throwing up) and CHILLS (Chills). At the time of the report, VOMITING (Throwing up) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Patient didn't take anything to treat the symptoms and also wasn't taking any other medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Headache, NauseaVomiting, arm hurt, tingling, fatigue, metallic taste Narrative:
had 4 of your shots; had 4 of your shots; Inappropriate dose of Vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "had 4 of your shots"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of Vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Took Paxlovid yet remained positive for 17-18 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: My healthy dad had 4 of your shots and still got very sick 6 weeks after last boost. Would have been hospitalized but hospital too full. Took Paxlovid yet remained positive for 17-18 days. He's still symptomatic. Week 4/5. It was unknown if patient took other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Day after administration the patient felt pain at injection site.  There was a large bulge described as the size of an orange.  It was red and painful.  The next day the bulge still existed but became itchy and less painful but appeared to be same size.  Advised to seek medical care.
pt recv vax 18MAY95 & 10DEC97 pt devel vesicles all over body no particular spot;
Mother of child called at 11:40 AM 10/29/13. States child had adverse reaction at 12 Noon 10/29/13 of pain radiating from L side of the neck and the shoulders/torso with 99-100 degree C fever relieved by Motrin. Advised to take child to PMD for eval.
This spontaneous report as received from a male patient of unknown age reporting on himself. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dosage, and lot number unknown). The patient reported that he developed shingles after receiving ZOSTAVAX. The outcome of he developed shingles was unknown. Additional information is not expected.
Rashes at injection sit after a week and muscle pain, exhaustion and the rash spread to other area of my body
he developed a bump on his left elbow; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program Pfizer First Connect. A male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspeciied date, the patient developed a bump on his left elbow by where the shot was given. He stated that it was the size of a half golfball. Outcome of the event was unknown.   Information on the lot/ batch number has been requested.
second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine; second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine; Covid19; Covid19; This is a spontaneous report from Pfizer program. A contactable consumer (herself as patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Mar2021 (Batch/Lot number: Unknown) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Mar2021, she had Covid19 virus after getting the first dose. On an unspecified date, the patient missed the second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine. The patient got the first dose of the vaccine 27Mar2021 and was scheduled on 17Apr2021 to get the second dose. However, she had Covid19 virus after getting the first dose. The patient missed the second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine. The events drug ineffective and Covid19 were assessed as serious as medically significant and remaining events were assessed as non-serious. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On day of vaccination, approximately 5 hours after vaccination, the area on left arm approximately 2" below the inection site became reddened, warm, swollen (with induration approximately 3" diameter), and itchy.  The site itself did not seem affected.  Later in the evening, the site and surrounding area became sore, but a tolerable soreness.  The are 2-3" below the injection site continued to be red, swollen, sore, warm, and itchy for almost 1 week.  On approximately third day after the vaccination, the reddened area (2" below the injection site) developed tiny pimple-like spots; raised and itchy.  They looked like tiny bug bites, but there was no evidence that I'd been bitten by bugs and in that area.  On approximately day 4-5 after vaccination, the tiny bumps became weepy, then scabbed over a day or so after that.  The itching decreased and was gone by approximately 10 days or so afer vaccination.  By the third week after vaccination, the spots were dried and gone, and the soreness was almost gone.  Redness and swelling lasted about 7 days.
I am not sure if I selected the correct brands for these vaccines. I can?t see on the patient system which brands they were so I am going off of memory. Both rounds of his vaccines now (2 and 4 months), my son has gotten horrible vomiting and diarrhea following his vaccines. It is Monday, he got the immunizations Friday, and he is still vomiting and having diarrhea (he just threw up again as I was filling out this form). He has 6 bottles a day and has been throwing up 4-5 times in between every single one of them, and today alone he has had 4 diarrhea blowouts in his diaper.
My son received this vaccination at the clinic. We were not asked to wait after the vaccination and 7 min from the time the vaccine was given he had a seizure in the front seat of my vehicle in the parking lot of the facility.
Case number PHEH2014US025127, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 77-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Clot on the lower left leg; foot and ankle swollen; A spontaneous report was received from a physician concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced foot and ankle swelling (joint swelling) and clot on the lower left leg (deep vein thrombosis).  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 5 Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) via  intramuscular route  on left side for prophylaxis of COVID-19 infection.   On 5 Mar 2021 prior to the onset of the events, the patient received their  second planned dose of mRNA-1273 (Lot number: 036A21A ) via  intramuscular route  on left side for prophylaxis of COVID-19 infection.   Doctor found a clot in her lower  left leg. Patient said that on Feb 2 before receiving the first dose on Feb 5 needed to have an x ray and blood work due to foot and ankle got swollen. Patient said they checked it for different things and that the doctor thought It would be a pseudo gout. As the ankle was still swollen patient went to her family doctor and doctor insisted to have a test for deep vein thrombosis. They have found a clot on the lower left leg. The patient had stated she have not a had a surgery or an injury and that it happened between doses. Treatment drug used for the event included was apixaban.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome for the events, foot and ankle swelling and clot on the lower left leg, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. It was reported that the patient had an x ray and blood work due to foot and ankle swelling before receiving the first dose of vaccine and that the doctor thought it to be a pseudo gout.
Fever; Pains in body; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot Number not reported) dose 1, via unspecified route on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got covid vaccine 2 weeks ago. And experienced fever and pains in body afterwards on unspecified date. The clinical outcome of the events were unknown.     information about lot/batch number requested.     Follow-up (12May2021): Follow-up attempts completed. No further information expected.