chrisvoncsefalvay/vaers-outcomes huggingface dataset:
21 months old patient received a 4th dose; 21 months old patient received a 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 21-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date 17th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2022, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's comments: The reporter consented to follow up. Additional Supportive Information: The patient received 4th dose of Pediarix at 21 month of age, which led to extra dose and inappropriate age at vaccine administration
15SEP : Tiredness. 16SEP : Fever, vomiting (traces of blood), headache. 17SEP : Headache, mild fever.
Redness(presently over 3 days) which grew in size (approx. 4"x 1/2")swelling, soreness, hardness. Appears to be lighter on 3rd days. Used ice, took TYLENOL, applied hydocotizone cream lightly over period of days. Received the one shot shingles vaccine in 2009. Consent form only said Zoster. Not sure of which Zoster to check. This was the first of two shots to be given. It's the newest 2-shot one. Not sure if I should get the 2nd part of this vaccine.
This case was reported by a physician and described the occurrence of fever in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 10 years ago). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, malaise and generalized rash. On an unknown date, the outcome of the fever, malaise and generalized rash were unknown. It was unknown if the reporter considered the fever, malaise and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient refused to receive the 2nd dose of SHINGRIX. Then she received her 1st dose of SHINGRIX six months ago. She developed fever, malaise and generalized rash that has persisted since that time.
diffuse, hot, swollen area, 6x4" on lt upper arm;treated w/ice & APAP;too many yr to recall last prior tetanus dose;
No adverse event; patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) in a 38-year-old patient of an unknown 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 27-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Sep-2022, the patient experienced UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose) 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 UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose).    Concomitant product use was not provided by the reporter.  The patient received a COVID booster of the bivalent vaccine today and received a 0.25 mL instead of the 0.5 mL dose.  She requested for a call back for guidance for this patient.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a nurse concerning a 11 year old patient who on 11-AUG-2010 was vaccinated with ZOSTAVAX (Merck) into the right deltoid. On 11-AUG-2010 the patient was to receive VARIVAX (Merck), but received ZOSTAVAX (Merck) instead. No adverse effect noted as of the reporting. Follow-up information from a nurse indicating that the patient had no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions. The administering nurse had inadvertently taken the wrong box of vaccine out of the freezer. No adverse events were reported. Additional information is not expected.
ipol was inadvertently administered to a patient instead of the intended dose of tubersol with no reported adverse event; Initial information received on 12-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 61 years old female patient who experienced ipol was inadvertently administered to a patient instead of the intended dose of tubersol with no reported adverse event while receiving vaccine Ipv (Vero) [Ipol] and while treated with Tuberculin Test [Tubersol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Apr-2022, the patient received a dose of suspect Ipv (Vero) 0.5 m of frequency: once (1 day) lot T1E872M via intradermal route (form, strength, lot number, expiry date and administration site: unknown) for Immunization.  On an unknown date, the patient started taking Tuberculin Test Solution for injection (form, strength, dose, lot number, route, expiry date and administration site: unknown) for Tuberculosis immunization.  On 12-Apr-2022 the patient developed a non-serious ipol was inadvertently administered to a patient instead of the intended dose of tubersol with no reported adverse event (wrong product administered) following the administration of Ipv (Vero) and Tuberculin Test.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Passed blood; Weak; Bad stomach cramps; Chills; Very tired; Vaccination site really sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BLOOD URINE PRESENT (Passed blood), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps), CHILLS (Chills), FATIGUE (Very tired) and VACCINATION SITE PAIN (Vaccination site really sore). On 15-Jan-2021, the patient experienced BLOOD URINE PRESENT (Passed blood). At the time of the report, DIARRHOEA (Diarrhea), BLOOD URINE PRESENT (Passed blood), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps), CHILLS (Chills), FATIGUE (Very tired) and VACCINATION SITE PAIN (Vaccination site really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details not reported by the reporter. Treatment details not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.
Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.
Patient is fully vaccinated. Hospitalized due to Covid.  Patient stated that she started feeling symptoms about a month before getting tested on 8/9. Her symptoms were difficulty breathing and extreme fatigue. She went to local hospital on 8/10 because her breathing was getting worse. That day, she was admitted. Doctors told her she had blood clots in her lungs. She was cared for and given medicine.
Day 8 after MMR fever 103 and maculopapular rash. Symptomatic treatment. Also had enlarged cervical nodes, red throat without lesions, mild runny nose. No pruritus.
pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant and received vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (first dose received on 30 Dec 2020) on 30-Dec-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and OMEPRAZOLE.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. The patient's last menstrual period was on 16-Dec-2020 and the estimated date of delivery was 22-Sep-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant and received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant and received vaccine) had resolved.     No treatment information was reported by reporter.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered EXPOSURE DURING PREGNANCY (pregnant and received vaccine) to be not related.
The pt broke out in hives in the afternoon of 2/1/01. Was given Prednisone. The pt decreasing dose for 8 days. Also was seen at a hospital for hives.
On 10-1-2022 at approximately 16:00 pt. developed a headache, muscle fatigue and feeling really tired. Pt. slept on and off until about 19:00. Pt. ate toast and went to bed by 20:00. Pt. woke at 03:00 on 10-2-2022 with severe headache, very sore muscles, very hot body and sore throat. Pt. woke up on and off several times more until about 06:30. This is when I did take her temperature and it was 99.6. At approximately 07:30 she drank 6oz of hot Orange Tang and by 08:00 she was vomiting. I did not treat with any medication. At the time of reporting this 13:37 on 10-2-22 her headache has decreased, muscle aches have decreased, body temp is 99.0, sore throat severity has decreased. Pt. ate a few saltine crackers and some cranberry juice without vomiting. At this time, 10-2-2022 13:44, I do not feel I need to take her for medical attention.
After 5-6 hrs of receiving annual flu vaccine - throat felt like closing coughing - irritation throat -bronch area.
Headache, Myalgia, Arthralgia, Fever, Chills, Fatigue Narrative:  Other Relevant History:
In ER 10/26/03 2:10 PM (99.9 (TM) 138 24). Fever, rash over torso for 24 hours (macular-not vesicular). Also macule at site of MMR injection left thigh.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot E K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There were no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reports that she felt nauseous the next day with some vomiting.  She also reports that she had diarrhea, fatigue and shortness of breath.  She states that her SOB worsened and she went to the ER on 7/18/21 due to her SOB and wheezing.  She was treated with prednisone and breathing treatments.  Pt states that she has continued to be short of breath since the vaccination on 7/9/21.
Booster; Accidentally burned her hands with a microwave bowl; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558) and received in response to mail trail sent regarding the confirmation of below mentioned query. The reporter is the patient. A 74-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Single), for COVID-19 Immunisation; Comirnaty (Dose 2, Single), for COVID-19 Immunisation. The following information was reported: THERMAL BURN (non-serious) with onset Dec2021, outcome "unknown", described as "Accidentally burned her hands with a microwave bowl"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster".  Additional information: Female consumer accidentally burned her hands with a microwave bowl. Caller wanted to know if she still had the immunity of the vaccine if she had received 2 doses and the booster dose of the Pfizer COVID vaccine and has underlying conditions. Caller withheld called in and stated that she had her two doses and a booster shot already and she was reporting that she had an accident two weeks ago in her kitchen. Her arms were burned by a microwave bowl. She wants to know if she still has the immunity of the Booster vaccine. She wanted to know if there was a loss of immunity in her body. Caller asking how long does it take to get full immunity from the booster. Caller also asking was there any test or blood work to test for immunity from the booster dose? Caller asking if she could get another booster dose (4th dose) after she had received the primary series and a booster dose already. Response: Provided disclaimer that Pfizer cannot recommend the use of the vaccine outside of what is approved, which was the primary series and a booster dose. Told caller we do not have information regarding a 4th dose or an additional booster dose and referred caller to the HCP. Seriousness was no.  The lot number for bnt162b2 was not provided and will be requested during follow up.
received 1st dose of Covid vaccine and then both of them got Covid; received 1st dose of Covid vaccine and then both of them got Covid.; This is a spontaneous report from a non-contactable consumer reported for on behalf of her husband via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This was the second of two reports. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The reporting consumer and her husband received 1st dose of COVID vaccine on 23Feb2021 and then both of them got COVID on unspecified date. Lab data included COVID-19 was positive on unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331587 same reporter, drug and event; different patient.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium
For the first few days, I had hives and was very itchy. Since then, I've continued to have a bump on my arm that looks like a large, pink bug bite. It's been almost a month, and it has not improved. Sometimes, I get another smaller bump nearby on my arm that comes and goes.
I had it at 10am on Monday and woke up at 3am at Tuesday morning with headache, shaking and fever. Body aches and all of that. So that continued through Thursday, I started feeling better by Thursday afternoon however I woke up at 4am Friday morning with a horrible cough. It sounded like I had Crip and I couldn't catch my breath and coughing up yellowish mucus. I had a low grade fever. I called the Doctor that day and he told me to continue my breathing treatments with the Nebulizer that I do 4 times a day and take Mucinex. I was really sick for a few days. I ended up calling the Doctor every Friday and could hardly speak cause I had Laryngitis because I was coughing so hard. The cough went for 2 weeks without getting better and got worse. The 3rd week on the weekend I went to urgent care that afternoon because I started getting a fever. They told me I shouldn't have gotten my vaccine because I was too close coming out of COVID and had too many antibodies. I also had an infection on my tongue with little bumps and it stings and I have a horrible taste when I eat certain foods - I take a swish and spit medicine I use everyday.  I have a  after covid care for long haulers with a Pulmonologist 7/2/2021.
Chills, 104 fever, extreme muscle aches, nausea, vomiting, over a 48 hour period
Two days after having PNEUMOVAX 23 injection patient reported to her MD for visit due to swelling and redness at injection site.
Patient received his second Pfizer vaccine on Friday. Saturday he came down with symptoms that we considered were like the stereotypical second dose. Fever, cough, shortness of breath, coming and going. It lingered until Tuesday, at which time he got a Covid test- negative. Went to dr, and he said there was a possibility of blood clots. Tests showed that he had severe pulmonary embolisms in both lungs- the main and 3 secondary arteries.
NO ADVERSE EVENTS REPORTED BY PATIENT OR GUARDIAN. PATIENT RECEIVED THE MODERNA VACCINE FOR COVID AND HE WAS SEVENTEEN AND A HALF YEARS OLD, AND NOT EIGHTEEN UNTIL DECEMBER.
Arm soreness; Headache; Achy muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headache) and MYALGIA (Achy muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headache) and MYALGIA (Achy muscle). At the time of the report, PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headache) and MYALGIA (Achy muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: follow up on 29-apr-2021 includes no significant information (only reporter email is updated)
nothing yet taking ibuprofen / Tylenol and bed rest .  I described the symptoms in earlier fields. I got the shot on the 15th of october and am still sick today ... 8 days
24 hours after injection right arm redness at injection site, increasing redness - now with 6" diameter redness - swollen and warm to touch with darker redness 1 1\3-3" in center. Referred to walk in clinic to see physician.
Received shot Wed am & Thursday am had severe  episode of vertigo.  I stayed at my son?s home Thursday.  I saw Dr  Froday since vertigo cpntonues  but is milder.  Dr. says it is coincidence.I disagree @ say it is a SE..
After 24 hours, generated severe swelling, redness and itching.  After 48 hours had continued to worsen. Urgent care prescribed medication: Cephalexin
patient was given the 12+ formulation, instead of the pediatric formulation - no known adverse effects per father
Welts on his face and chest; Welts on his face and chest / are sore; This case was reported by a consumer via call center representative and described the occurrence of welts in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles. Concurrent medical conditions included kidney transplant.   In December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced welts and pain. On an unknown date, the outcome of the welts and pain were unknown.   It was unknown if the reporter considered the welts and pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but it could be 60 or 61 years.  The patient received 1st dose of Shingrix in right arm. The patient experienced welts on his face and chest and the welts vary in size, were sore and appear intermittently. He had been to a dermatologist. All information was not available. The reporter consent to follow up.
Narrative: HISTORY OF PRESENT ILLNESS: The patient is an 82 y/o male with PMH of HTN, DM, and HLD who presents to ED after a fall. The patient reports that he unintentionally tripped over a curb today and fell. He reports he fell on outstretched hands, he denies other injuries. The patient states that he received the COVID vaccine. He denies fever, chills, SOB, cough, and chest pain. Upon arrival in the ED the patient was tachpnic and hypoxic with oxygen saturations in the 80s. He required 4L supplemental oxygen. COVID-19 testing was positive. HOSPITAL COURSE: PATIENT is an 82 yo M with acute hypoxic respiratory failure secondary to COVID-19 with likely underlying pulmonary fibrosis, on inpatient hospice for progressive dyspnea/hypoxia despite optimal medical treatment for COVID-19 pneumonia. PATIENT continued to decline significantly despite all measures of treatment. Family requested hospice care given grim prognosis. He was provided comfort care. Family was updated and multiple video conferences were completed by social work for visitation during end of life. Patient expired on 9/5/21.