chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 8 hrs after pt received RabAvert and RIg, pt developed headaches, nausea, muscles aches, chest pain (musculoskeletal), and dizziness.  Symptoms persisted over next 5 days but continued to improve.  On 5 Feb 2010, a second dose was given of RabAvert as HDCV not available and the above symptoms returned in approx 10 min.  Pt treated symptomatically for pain and nausea.
Began to notice blood in urine and increased in amount of blood in urine over time. Somewhat increase in frequency of urination as well.
Day 8 itching at injection site Day 9 red raised warm tender lump at injection site resolved over 48 hours
Information has been received regarding a case in litigation concerning a male with areflexic bladder, and a history of sinus congestion, cough and respiratory distress who on 24-NOV-1994 was vaccinated with a second dose of Recombivax HB. On 04-DEC. the patient experienced Acute Lymphoblastic Leukemia and was hospitalized. Reported from Litigation Report. "The office of Special Master's has ordered a petitioner to show cause why a claim that the hepatitis B vaccine caused a child's health problems should not be dismissed." The Special Master on 16-Oct, held that the patient's health problems were the result of acute lymphoblastic leukemia unrelated to the vaccine. The special master issued the following findings which the petitioners will have to answer to avoid dismissal: Hepatitis B vaccine does not cause acute lymphoblastic leukemia (ALL). The interval between the patient's second vaccination and the onset of his neurologic difficulties was three months beyond the period appropriate for linking vaccination to an autoimmune disease. The patient's onset of neurologic difficulties occurred while his brother had chickenpox. The patient's immune system was already compromised by his ALL and viruses, such as chickenpox, can lead to neurologic problems. Even if the vaccine caused a significant aggravation of the patient's pre-existing areflexic bladder, the sequelae of that significant aggravation did not last for more than 6 months as the Vaccine Act requires for compensation. According to the Special Master, the patient now 17, received his second hepatitis b vaccination on 24-Nov-1994. On 04-Dec, he was admitted to the hospital with a history of congestion, cough, and respiratory distress. Emergency room staff noted a "very abnormal" chest x-ray with an enlarged pleural effusion on the right side and a small one on the left. He also had a mediastinal mass. He underwent bone marrow aspiration and chemotherapy. Upon internal review, neurologic difficulties and worsening of significant aggravation of areflexic bladder were considered other important medical events. No further information is available.
three year old patient accidentally given Flublok vaccine with no reported adverse event;Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via non-healthcare professional via Medical Information (Reference number- 00855276).  This case involves a three-year-old patient (unknown gender) who accidentally received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], (product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on same day).   It was reported "Caller stated Flublok was accidentally given to 2 children and caller is looking for guidance. The caller would like to know what the follow-up and side effects would be from giving two patients under 18 years old the FLUBLOCK vaccine? See the additional event details field for more info. Additional Description of event Adverse events: The only info the caller has is that a Flublock vaccination was given to a 2 year old and 3 year old".  At the time of report, 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 the 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.  There will be no information available on the batch number for this case.
This spontaneous report as received from a registered nurse refers to a 8 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
April 15, 2021 in the middle of the night I went to the ER and was determined it was Bells Palsy. For 6 months I wore an eye patch on right eye. I still have some paralysis on the right side of my face.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated 03/19/21 and has since received dose 2 on 04/09/21
From 1/2-1 hour after injection patient experienced high fever, dizziness, fast heart rate and blurred vision for 10 hours.
This case meets vaccine breakthrough review. SxS include cough/congestion, weakness, fall.
MMR was given 6/19/2017. By 6/27/20017 mother noted redness and the injection site which increased in size. Child was evaluated in the clinic and diagnosed with cellulitis of the left thigh. Improvement was noted with oral antibiotics on 6/30/2017.
Patient had large amount of swelling, redness and fluid buildup in entire right arm one day post vaccination with PNEUMOVAX; patient also received a flu shot in other arm (left arm) with no adverse reactions. Pt was referred to emergency room for treatment.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication were reported. No treatment medication were reported.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  This case contains information for the 70 of 77 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Pt. states that after receiving the 2nd dose of Phizer 05/15/2021, started experiencing symptoms that evening of dizziness, vomiting, Fatigue, muscle ache, fever (99.9), joint pain, nausea, and swelling at the injection site. No noted Primary visit/communications. Symptoms subsided after 24hrs.
Heavy breathing & wheezing a day after. Turned into bronchitis and later pneumonia. Diagnosed with asthma.
Fatigue; Headache; Pregnancy; Soreness at the site of injection; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE PAIN (Soreness at the site of injection), FATIGUE (Fatigue) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Dilaudid) and Drug allergy (Imitrex).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Nov-2020 and the estimated date of delivery was 11-Aug-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Soreness at the site of injection). On 30-Dec-2020, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at the site of injection), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided. Estimated date of conception 17 Nov 2020 was reported.; Sender's Comments: This is a report of product exposure during pregnancy with associated AEs (soreness at the injection site, headache and fatigue) in a 38-year-old female consumer. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site pain, headache, fatigue) a causal relationship cannot be excluded.
EMS narrative: NARRATIVE  RESPONDED TOFE FIELD FOR A 54 YEAR OLD FEMALE HAVING ALLERGIC REACTION. ARRIVED ON SCENE TO FIND PT SITTING UPWRITE ON A BED. PT IS ALERT AND ORIENTED. PT DOES NOT APPEAR TO BE IN DISTRESS. STAFF MEDIC CLAIMS THE PT RECEIVED HER FIRST VACCINATION AND BEGAN TO HAVE A REACTION. PT STATES HER TONGUE BEGAN TO SWELL UP AND HAD DIFFICULTY BREATHING. STAFF STATES THEY GAVE THE PT BENADRYL AND SOLU-MEDROL. PT HAS ALREADY IMPROVED WITH THE MEDICATIONS. PT STATES SHE FEELS MUCH BETTER AND HAS NO SHORTNESS OF BREATH. PT SHOWS NO SIGNS OF ALLERGIC REACTION. PT WANTS TO BE TRANSPORTED. PT WAS ABLE TO STAND AND SIT ON THE COT WHERE ALL STRAPS AND RAILS WERE APPLIED. PT WAS BROUGHT TO THE AMBULANCE WHERE VITALS WERE ASSESSED AND MONITORED. PT WAS TRANSPORTED WITHOUT INCIDENT.T PT WAS BROUGHT INTO THE FACILITY WHERE CARE WAS TRANSFERRED TO RN.
Patient had vaccine about 3 weeks ago, she did not know the date, I could not find that info in the chart. She felt fine for a week.  Then developed body aches and severe neck pain.  It went away after 8-9 days.  She went to the ER during that time (2/3) and was negative for covid-19 and flu.
Fatigue, tired, muscle weakness, trouble breathing, pain in site of injection, clouded mind
It felt almost like a cold but it was really thick mucus and I was having like an Asthma attack. I used my inhaler. I had a 102 temperature for about a day and a half. Because our grandson have had direct contact with COVID, I went to urgent care to get tested. The test came back negative. They also tested me for Flu and it came back negative as well. They put me on Prednisone I think because of the Asthma. Yesterday was my last day with Prednisone but I still have a little bit of the phlegm.
At injection site there was a small raised area.  It was painful to touch.  There was also a red raised area of 6-7 inches in length and 2 1/2 inches wide.  It was hard and feverish and remained this way for 4 days.  The size has decreased to 2x2 inches in swelling and only minimal redness.  It is stil painful but has decreased everyday.
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 23-JUL-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K023534 and expiration date 22-MAY-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Had Varivax on 10/24/03. Rash started 11/5/03 on trunk of body. Red macules with central papals.
Pt recvd 3 doses of Engerix-B in 1990; recently it was determined that pt had neg titers; booster dose was administered & vax again tested neg;
Received first dose under the age of 18; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose under the age of 18) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose under the age of 18). On 02-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose under the age of 18) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.
Patient received second vaccination.  A small drop or two ran down the patient's arm, as the needle was not tightly affixed to the syringe.
Tinnitus noted three days post immunization. High pitched constant tone, both ears. First thought related to BP elevation 150/90, however no change in tinnitus with BP treatment.
developed a nodule; This is a spontaneous report received from contactable reporter (other healthcare professional).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Restylane defyne, notes: 6 months ago. The following information was reported: NODULE (non-serious), outcome "unknown", described as "developed a nodule".  Additional information: Reported patient had Restylane Defyne 6months ago and had a Covid-19 vaccine recently and developed a nodule. HCP was not sure which Covid-19 vaccine the patient received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain high in throat; pain in mouth roof/pain near nose inside mouth; pain under jawline; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (pain high in throat), ORAL PAIN (pain in mouth roof/pain near nose inside mouth) and PAIN IN JAW (pain under jawline) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (pain high in throat), ORAL PAIN (pain in mouth roof/pain near nose inside mouth) and PAIN IN JAW (pain under jawline).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   No relevant concomitant medications were reported.
Information has been received from a physician concerning a 16 year old female who in approximately July 2009 (about 1 month ago), was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported). The patient experienced a tonic-clonic seizure almost immediately after vaccination. Her symptoms resolved quickly in about 10 to 15 minutes. Unspecified medical attention was sought. No lab diagnostics studies were performed. On an unspecified date, the patient recovered. Upon internal review, tonic-clonic seizure was determined to be an other important medical event. Additional information has been requested.
Patient had come in to get the flu shot, instead was given Pfizer covid vaccine, however pt is a Moderna patient. Patient was followed up on and experienced some high blood pressure.
Patient was in office for her annual exam, states she received first Pfizer dose on 4/10/2021 at another location, I gave her the option to get her second dose as we have them on hand, she agreed, after giving her the Pfizer vaccine 10-15 minutes later she found her card and it was Moderna vaccine that she had received first on 4/10/2021 not Pfizer. No adverse reaction after 15 minute observation time occurred.
PT WAS GIVEN VARICELLA IN THIGH.  HAD A DELAYED REACTION 1 WEEK LATER.  MOTHER CALLED TO NOTIFY OFFICE THAT AREA IS RED, RAISED AND HOT TO TOUCH.  AREA IS ABOUT THE SIZE OF A HALF DOLLAR.
(R) arm red, swollen and tender. Fever 102.8. No diarrhea or vomiting. Appetite is good.
No additional AEs reported; Caller reported VARIVAX administered after temperature excursion.  Caller states the Lot number and expiration date was incorrectly documented as W031810 10/5/2023 but the administered VARIVAX was actually W034708  11/1/2024.  No other information pr; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 19-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, by intramuscular route, lot # W034708, expiation date: 01-NOV-2024 (validated internally), for prophylaxis (Strength and anatomical location were not reported) which was administered after temperature excursion (product storage error). The temperature was 6.4°F during a time frame of 42 minutes. No previous temperature excursions neither additional adverse events (no adverse event) were reported.     This is one of several report received from the same reporter.; Sender's Comments:  US-009507513-2305USA007991: US-009507513-2305USA007944:
lot number involved in a RECALL was administered; lot number involved in a RECALL was administered; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received the recalled lot of Engerix B, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. The reporter would like to knowdid need to inform patients and revaccinate them and need to report this situation. The reporter consented to follow up. This was 1 of 10 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223917:same reporter US-GLAXOSMITHKLINE-US2021AMR223918:same reporter US-GLAXOSMITHKLINE-US2021AMR223919:same reporter US-GLAXOSMITHKLINE-US2021AMR223916:same reporter US-GLAXOSMITHKLINE-US2021AMR223915:same reporter US-GLAXOSMITHKLINE-US2021AMR223914:same reporter US-GLAXOSMITHKLINE-US2021AMR223920:same reporter US-GLAXOSMITHKLINE-US2021AMR223912:same reporter US-GLAXOSMITHKLINE-US2021AMR223913:same reporter
12 hours after injection..... fatigue, headache, muscle aches, joint pains, chills, nausea, fever (99.9) all of these lasted about 12 hours..... took ibuprofen.... most symptoms subsided over time but left with headache  the next day. Also, 48 hours later, broke out in a red, splotchy rash ....... small spot below the injection site but much larger area scattered over my torso.  Not itchy, just annoying...... fading after 2 days.....
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient was allergic to azithromycin and sulfa drugs. On 09-OCT-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml) (lot # L020482 with an expiry date of 02-SEP-2016) subcutaneously. No concomitant medications were reported. On 12-OCT-2015, after vaccination the patient experienced very bad itching on her back. The itching became painful and the on 15-OCT-2015, patient visited her physician. The patient was diagnosed with shingles. Patient received treatment with VALTREX on 15-OCT-2015. The outcome of the event herpes zoster was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.