chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; he patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; The patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; This spontaneous report was received from a physician and refers to a 12 month old female patient. The patient had no known medication allergies, or significant medical history. The patient's concurrent conditions were not reported.     On 15-JAN-2021, the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T010651, expiration date 22-SEP-2021 in the right thigh; with a dose of   varicella virus vaccine live (oka/merck)(VARIVAX) lot # S033540, expiration date 22-OCT-2021 in the right thigh (MARRS # 2102USA007091); and with a dose of hepatitis a vaccine, inactivated(VAQTA) lot # T014836, expiration date 17-JUL-2021 in the left thigh for prophylaxis (dose and route were not reported). The vaccines were administered in the private Doctor's office with a private funds. Other suspect therapy included sterile diluent. Concomitant therapy included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR).   On 25-JAN-2021, the patient was in the clinic with a fever with a temperature maximum of 103.5 (units not reported) (pyrexia) and "red macular rash on her torso" (rash macular) that was being treated as "viral otitis media" bilateral (otitis media viral). The patient was being treated "symptomatically and conservatively" with a prescription of amoxicillin, 400 milligrams per 5 milliters, 3 milliters twice a day to begin in 2 to 3 days if symptoms persist or get worse.  At the time of the report, the outcome of the events and the relationship with the vaccines were not reported.  This is on of two reports regarding the same patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2102USA007091:Original Case : 2101USA009289
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient developed sweating, pale lips, fatigue/lethargy, eyes closing and hard to remain concious. pharmacist called 911 and paramedics came, evaluated patient and blood pressure / heart rate normalized. patient able to sit down. after 30min post vaccination. patient and patient's father agreed to go home and refused ER service from paramedic.
Patient developed severe pain to the touch and erythema at site of pneumococal injection and proximal to the injections.  Symptoms continued until Tuesday 11/11/2014.
pt cried x 4 hrs straight; temp of 102; APAP given, ice pack to leg; pt cont to cry-stop crying p/few hrs; temp cont x 1 wk of 101 to 100; fever went away w/APAP but soon returned afterwards;
ERYTHEMA NODOSUM; VAGINAL BLEEDING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 0418218 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced vaginal bleeding. On 29-APR-2021, the subject experienced erythema nodosum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal bleeding on 10-JUN-2021, and had not recovered from erythema nodosum. This report was non-serious.
This spontaneous report as received from a pharmacist refers to an approximately 63 year old female patient. On 21-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J011212, expiry date 29-AUG-2014) dose 1, subcutaneous in the right arm. No concomitant medications were reported. On 22-NOV-2013, the patient experienced redness at injection site, warmth at injection site and pain at injection site. The outcome of pain at injection site and warmth at injection site was reported as recovered. It was reported that the patient still had a 2 inch diameter area of redness at the injection site. The outcome of redness at injection site was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Pt received 1st dose of Pfizer on 3/17/21 at 2pm in right arm. Then, on 3/18/2021, at 7pm, patient noticed rash under armpit of left arm while in the bath. Patient called PCP who instructed her to take benadryl. Rash progressed, so patient went to ER. ER doctor recommended patient not take any further medication (patient had already taken benadryl prior to going to ER). 3/19/2021 patient decided to continue benadryl 25 mg three times that day. By 3/20/2021, rash had progressed further down her legs, so patient returned to the ER. Rash was only on the arms and legs, and was NOT on torso or chest. No itching, no SOB, no lip/tongue swelling, no fever. In ER, patient was instructed to continue benadryl and was given medrol dose pack, which she was encouraged NOT to take. Patient discharged from ER and returned home. On 3/21/21, new lesions were still appearing, and patient was told to visit PCP on 3/22/2021. On 3/22/2021, patient noticed her left hand was swelling, so medrol dose pack was started. Patient had dramatic improvement in rash and swelling with 24 hours of steroids. On 3/25/2021 patient returned to PCP,  rash was resolving well.
pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; gray discoloration; muscle atrophy; Indentation; This is a spontaneous report from a contactable 49-year-old female physician reported for herself. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via an unspecified route of administration on 23Dec2020 07:30 at single dose at left arm for covid-19 immunisation. Medical history included allergy: walnuts. Concomitant medication within 2 weeks of vaccination included medroxyprogesterone acetate (DEPO PROVERA). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced initial pain and small SQ bump. After 1 week, red and swollen 2x3cm, firm. No pain, no warmth. About 2 weeks after, swelling gone, but gray discoloration on 2x3 cm area. Now after 3 weeks, same area with muscle atrophy. Indentation and mildly achy. Adverse event start date was reported as 30Dec2020. Patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included nasal swab, SARS-CoV2, NAAT: negative on 05Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of event swelling was recovered, and outcome of other events was not recovered. The report is considered as non-serious.
right after injection had a indescribable feeling going through rt. arm kind of felt like circulation was off. next day had a taste of metal, sore arm and sharp pain in chest behind rt. breast, that continued on and off for weeks. about 2 weeks after shot, woke up with tingling in shoulders arms and hands for a few days. tingling pinching and burning sensation in rt. ear, tingling and numbness on rt. side of face from lips to ears. ringing in both ears pain in back of neck with tingling running down back of neck head and shoulders. strange feeling in rt. arm like it had a rubber band on it.sharp stabbing pain in rt. arm pit lasted one day then would happen occasionally. mild swelling in arm pit sharp stabbing pains under rib cage ,hands and feet . tingling legs hands and feet. rt. foot very cold had to use heating pad nothing else worked.heart palpitations about he same time in evening for several days in a row. chills on and off for a few days confusion, brain fog and hard to concentrate and remember things.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored ROTATEQ (dose, strength, route, frequency, lot # and indication unknown) (incorrect product storage). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Injection site pain that worsened to limb weakness in limb of injection, gradually improving today at 5 days after injection.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reported batch number of SHINGRIX was updated from 3Z414 to 3Z4KL, as per sales data sheet. The patient received SHINGRIX in left arm and experienced redness and swelling below the injection site. The pharmacist reported that the patient was already followed-up with her physician. The reporter reported that the date of onset for the redness and swelling was unknown.
Patient was given a covid pfizer vaccine number #3.  Patient was assessed post injection for 20 minutes and no adverse reactions present only right arm and soreness. Patient was assessed post injection by physician as well.
Diagnosis: acute pericarditis and acute myocarditis.   Patient received Moderna  Covid19 vaccine 1st dose 4/21/2021  LOT 037A21B to left arm. Stated he had sore arm. Patient received Moderna Covid19 vaccine 2nd dose on Tuesday, 5/25/2021 LOT 044B21A to right arm. Tuesday afternoon he developed a fever but did not take his temperature. On Thursday morning (May 27) he was at rest and stated that's when he first felt chest pressure. Chest pain got worse since yesterday, prompting  a visit to urgent care then urgent care sent patient to ED. Denies shortness of breath, dizziness, cough, or other associated symptoms. complains of anterior chest pain, does not radiate.  non smoker.   trop 3.79, CRP 35.4; sed rate 17, EKG . ED physician consulted with cardiologist. Patient given ibuprofen  600 mg PO x1 in ED and discharged on ibuprofen and will be following up with cardiologist. discharge dx by ED doc: acute pericarditis and acute myocarditis
Initial information received on 28-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old male patient who received vaccine DIPHTHERIA AND TETANUS TOXOIDS instead of ADACEL. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer, number in vaccine series- 6, lot number, expiry date not reported via unknown route in unknown administration site instead of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, lot number, expiry date not reported. It was an actual medication error due to wrong vaccine administered. It was reported that a patient who received Td when they should have received ADACEL. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
administered a Moderna vaccine past the 12 hour shelf life post opening the vial; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered a Moderna vaccine past the 12 hour shelf life post opening the vial).    No concomitant drug information was provided.  Reporter stated that when they referred to the CDC's page for administration errors and deviations, the BN medical information line was listed.  No treatment drug information was provided.   Reporter did not allow further contact
Tender in left upper arm. Can still see where the shot was given; and discolored where it was red.
Received dose from vial that had black particulates in previous syringe; Received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Particulate was thin,slightly smudged and broke apart when lightly touched it with the end of a pen. Concomitant products were not provided. Treatment medication were not reported.
noticed while reviewing vaccine submission to immunet  on 12-08-2021. spoke with grand mother and told her to bring her card. she brought it today 12--13-2021 and the card has moderna listed as dose -1
Patient and husband came into pharmacy to ask about reaction she was experiencing. She had a very large welt at injection site and it was red, painful and itchy. Husband is MD and gave her prednisone and hydrocortisone cream which is helping.
2 days following injection, pt seen for fever, chills, red spot size of sm plate, itchy, red, painful right arm locally, myalgias. DX with cellulitis treated with Keflex.
Extreme exhaustion for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administrated in Left arm on 21Feb2021 10:00 (age at the time of vaccination 60-years-old), as a single dose for COVID-19 immunization. The patient medical history included Rheumatoid arthritis. The patient concomitant medications were not reported. Patient took other medications in two weeks was not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 21Feb2021 12:00, the patient experienced Extreme exhaustion for 24 hours. Patient did not received treatment for adverse event. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up (28May2021): Follow-up attempts completed. No further information expected.
Shortly after vaccination, the pt had a syncopal event. This was discovered by an observer. Initial systolic BP was 90, HR 50 and SP02 99%. No skin, respiratory or airway involvement. No signs of an allergic reaction. Pt improved after 20-30 minutes of extended observation. EMS services were not required.
Redness and swelling at and around injection site (upper arm) and down to elbow. Accompanied by pain and skin warm to touch. Reaction occurred 2 days post vaccine. Treated with oral BENADRYL. Right side.
Father states that family, including patient, had mildly upset stomach prior to taking vaccination. Child took first pill of 4-pill series at approximately 2040 on 2/9/19. Father states he thought he was giving child antacid but accidentally gave him laxative around one hour later. Then at approximately 2205 child vomited. Father states that child's mother claimed to see the pill in the vomit. Father states that child did not have fever, hives, or difficulty breathing, and felt better after vomiting. Father states child has had no issues since, but has not resumed taking remaining three vaccine pills.
Initial report received from a physician on 02 Mar 2011: This patient was vaccinated with second dose of RABIPUR (batch number 486011A) on 17 Feb 2011. The patient had tolerated first dose. Ten minutes after second dose, the patient developed globus pharyngis and had compulsive throat clearing. One hour after vaccination, the patient developed exanthema which led to hospitalization. Final event outcome was reported as completely recovered.
painfully sore left arm beginning the evening of the shot and continuing for 3 days.  Pain radiated from elbow up to neck and caused limited range of motion light headed,  headache, severe muscle ache every joint  lasting 3 days rash on torso at day 3 not itchy but red
Constant vomiting; cannot keep anything down except smoothies and water; cannot keep down gatorade, soup, bread, etc.
Adverse event: Inflammation  *Symptom: raised sore bump on left thigh Treatment: Bandaid  Outcome: Nine days later the area is no longer sore but it feels tough under the skin and slightly red.  *Symptom: Soreness in left foot Treatment: None Outcome: Nine days later and the foot is still slightly sore  *Symptom: Raised red bump on back of head, left side. Treatment: None Outcome: The bump diminished within two days and is gone now.
Cellulitis of left upper limb. Red, swollen, painful, fever 101, chills, sweats.
My son got the second vaccine shot at work and he works I don't know the lot number or any of those types of numbers
2 wks p/recvd flu vax pt exp lt intercostal pain w/difficulty breathing; pain was initially attributed to the face that pt was using only 1 crutch on the rt side; pt seen by MD who felt intercostal pain was due to crutch use;
Patient received the first dose in his left arm through a tattoo, and swelling and itching occured over a large portion of the shoulder but in line with the borders of the tattoo; it did not extend beyond the tattoo. Patient believes the vaccine had reacted specifically with the ink of the tattoo. The second dose was given in his other arm through a different tattoo that he received at a different tattoo parlor, but he did not have any issues. The doctor gave him silver sulfadizine and mupirocin, neither of which seemed to help. Patient already takes prednisone for chronic health issues.
At site of injection, 3 red spots appeared on Day 5, grew larger for 2 days , looked like a rash (maximum size 3 x 5 inches), then dissappeared within 24 hours.  Arm and all upper arm muscles noticeable sore for 48 hours, then better and then got sore again and felt hot during the time the rash was visible.  Sorness left when rash dissappeared.
Per patient's mother, she had a episod of unconsciousness with fever of 105 degrees F.
total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C, 30 minutes with a minimum of 12.3C and maximum of 15.6C, 1 hour with a minimum of negative 1.8C and maximum of 1.8C with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received from health professional received on 29-Apr-2022.  This case involves a 17 years old patient of unknown gender who was administered vaccine with reported total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2021, It was reported that temperature excursion of Menactra vaccine occurred with total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, on 19-Oct-2021,  temperature excursion occurred with 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event (product temperature excursion issue). On 01-Apr-2022, the patient received a dose of suspect Menactra vaccine (lot U7268AA, expiry date: 22-Apr-2023) (formulation, strength, dose, lot number, expiration date, route of administration and administration site: unknown) as prophylactic vaccination (immunization).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.