chrisvoncsefalvay/vaers-outcomes huggingface dataset:
50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 019H22A and 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jan-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event) had not resolved.        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 WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent).    No concomitant medications were reported.  No treatment medications were reported.
Moderna COVID-19 Vaccine  EUA Nausea, vomiting, headache and body aches for about four-five hours.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 09-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
RIGHT ARM PAIN AROUND INJECTION SITE (PAIN LEVEL 8); This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included pacemaker stent in right artery, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, Laboratory data included: Laboratory test (NR: not provided) unknown. On 27-MAR-2021, the subject experienced right arm pain around injection site (pain level 8). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from r arm pain around injection site (pain level 8). This report was non-serious.
He has chills; He probably got a fever/fever was 100.6 (unit not reported); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 89-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 89 years, in arm for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (Dose 3), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 2), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 05Nov2023, outcome "unknown", described as "He has chills"; PYREXIA (non-serious) with onset 05Nov2023, outcome "unknown", described as "He probably got a fever/fever was 100.6 (unit not reported)". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient's spouse reported that they got the shot on 04Nov2023. The vaccine was administered to the patient in the upper arm. Reportedly, the patient woke the next morning and said he has chills and that he probably got a fever. It was confirmed that the patient's fever was 100.6 (unit not reported). The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Nausea, vomiting, difficulty sleeping, fever peaking at 102.4°f
ACHY; SWEATY; BURNING BEHIND THE EYES; LOW GRADE FEVER; SORE AT INJECTION SITE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinusitis, penicillin allergy, hashimoto's, epstein barr, minor palpitations, non alcohol user, non smoker, and thyroid nodule, and other pre-existing medical conditions included: The patient had no drug abuse or illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Concomitant medications included loratadine. On AUG-2021, the patient experienced achy. On AUG-2021, the patient experienced sweaty. On AUG-2021, the patient experienced burning behind the eyes. On AUG-2021, the patient experienced low grade fever. On AUG-2021, the patient experienced sore at injection site. On AUG-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100 Fahrenheit. Treatment medications (dates unspecified) included: vitamins nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore at injection site, and had not recovered from low grade fever, fatigue, burning behind the eyes, sweaty, and achy. This report was non-serious.
arm is a little painful; itchy; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and itchy upper limbs. On an unknown date, the outcome of the pain in arm and itchy upper limbs were unknown.   It was unknown if the reporter considered the pain in arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: On Wednesday from the date of reporting, the patient received Shingrix. The patient felt ok but the arm was a little painful and itchy. The patient asked do it need to worry. The patient referred to his/her doctor for treatment of painful and itchy arm. The patient was satisfied with the information provided by the representative, and stated that usually, the patient did not have the reaction to vaccine however this was unusual.
10may90 pt vax hepta B. w/i few hrs pt devel arthritis which described as synovitis and stocking paresthesia which became more severe over next 4-6 hrs.  sx persisted
This case was reported by a healthcare professional and described the occurrence of the throat feeling tight in a 24-year-old female subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medications included unknown (Depo), Sertraline hydrochloride (Zoloft), Guaiphenesin (Mucinex) and Clartin-D (Claritin D). On 11 October 2007 at 15:30 the subject received unspecified dose of Flulaval, the subject expereinced a slight sensation of  throat tightness and swelling. The events were resolved by 15 October 2007. Causality was not known.
excessive salivation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 08Jan2022 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SALIVARY HYPERSECRETION (non-serious) with onset 09Jan2022, outcome "unknown", described as "excessive salivation".  The lot number for BNT162B2 was not provided and will be requested during follow up.
pt recvd vax 2OCT93 & again on 5OCT93; pt did not exp any adverse events; pt has a h/o mental retardation, cardiovascular accident, diabetes & anemia;
Arm soreness that evening and the next morning. Later in the afternoon the next day, my other arm felt sore and was aching. 2 days later, I developed a sore throat and general malaise.
Information has been received from a registered nurse concerning a patient who was vaccinated with one dose of PNEUMOVAX 23 (lot # 662667/1435X). The patient had cellulitis like arm reactions, body aches, headaches, fever and dizziness after the vaccination. It's unknown if the patient had sought any medical attention. A lot check for PNEUMOVAX 23 was requested. Follow up information received from a nurse who reported that the patient's symptoms were the worst because she was immunocompromised. She had leukemia. The patient was considered to be recovered at the time of this report. A standard lot check investigation was performed on Lot # 662667/1435X. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
discomfort at injection site; little arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort at injection site) and PAIN IN EXTREMITY (little arm soreness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (little arm soreness). On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (discomfort at injection site). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort at injection site) outcome was unknown and PAIN IN EXTREMITY (little arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Patient did suffer from bruising, petechia head to toe 2 weeks after the vaccination.  Patient platelet count on the day of exam was critical.  He didn't have intracranial bleed or intestinal  bleed.  Patient was rushed to ER and was admitted at hospital.
Pt recvd 1st dose of Hep B vax on 8MAY92 w/in 24 hrs devel non-pruritic rash described as blotchy, red & irregular by a fever 102; pt recovered;
Initially patient felt pain upon immunization. After two hours patient had a very painful right arm and could not move it. Required ER visit, right arm.
No signs or symptoms.  I had a baseline CBC in November of 2019 with WBCs within normal range prior to a scheduled tonsillectomy. I have no medical history. Surgical history only includes the tonsillectomy in December of 2019. I have no history of abnormal lab counts. My white blood cells continue to be less than 3, currently 2.2 with a hematologist from Cancer Center now following. I've had a bone marrow biopsy as well to rule out leukemia and lymphoma. Because my WBCs and neutrophils (now 1.1) have been low since March, I am now considered to be diagnosed with Neutropenia as a chronic case.
Patient has been experiencing intermittent rash 2-3 times per day resembling hives in small patches on his body.  symptoms began 1 week after vaccination and have been persistent.  Notes that he is almost  8 weeks post vaccination in symptoms have been slowly improving with decreased in severity as well as frequency.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included INFLUENZA VACCINE for prophylaxis. On 24th August 2018, the patient received the 1st dose of SHINGRIX and INFLUENZA VACCINE. On 24th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th August 2018, the patient experienced nausea. On 27th August 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the nausea was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and flu vaccine in right arm. Before being given the vaccines, the patient did ask if there would be a problem with taking both vaccines together. She was told by the pharmacist that it should be fine. She did mention that the arm she received SHINGRIX in was worse as far as soreness. The nausea started on the day of reporting and it had been very bad, she said. She did not know if it could be from both vaccines or not. The manufacturer for the flu vaccine was Seqirus.
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SA21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Fever up to 100 degrees -> for one day. Injection site swollen, red -> for approx. 2 days. Went to primary care clinic-staff/doctor reported patient had allergies -> placed on MEDROL DOSE PACK/FLONASE spray/CLARITIN.
The pt experienced severe fatigue, night sweats, forgetfulness, poor concentration, and cold intolerance.
This spontaneous report as received from a pharmacist refers to a newborn patient of unknown age. On 10-OCT-2012 18:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I received my 4th dose on 07/15/2022 and my adverse event started with in couple of hours of the vaccine, swollen arm; muscles aches; my joint hurts; rash on my back, face, and chest; itching; nose hurt; and eye hurts. I went to the rheumatologist who prescribed me steroids and then I went to my regular doctor gave me antibiotics and ALLEGRA. I was on the medication for 10 days. I am fine now.
Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion; Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion) 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)) (batch no. AS7168B) 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 (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion) 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)) (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 (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Multiple excursions over the period of 11Dec2022 through 15Dec2022/2 Vials administered post excursion).    Concomitant medications were not reported.   Treatment medications were not reported.
Patient returned to pharmacy about 45 minutes after receiving vaccine, stated "not feeling well" and "felt like she was going to have a seizure." We grabbed a chair to seat her and called emergency services to get an ambulance to come pick her up. While waiting for ambulance spoke with patient, she said her symptoms were similar to the last time she had a seizure where she felt very anxious, her heart rate increased significantly, and felt very fatigued. Fell asleep briefly as first-responders arrived in pharmacy.
No additional AE information; temperature excursions/ it was administered to patients; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.   On 10-FEB-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # S027465, expiration date was reported and also established as 02-MAR-2021 (strength, route of administration and anatomical location were not provided) for prophylaxis (improper storage of product in use). The nurse was unaware, that the vaccine before administration to the patient, was going through temperature excursions on an unspecified dates since 01-NOV-2020 through the end of an unknown date in February 2021, which was detected by the digital data logger. The data logger log list was provided. It was unable to assess the exact dates of excursion for the administered vaccine. The reporter was concerned about repeating the vaccination due to excursions. No additional adverse event (AE) information was reported (no adverse event).  This is one of several linked reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA000947: US-009507513-2103USA001002: US-009507513-2103USA000942:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Patient stated that about 3 days after receiving vaccine, she had pains in the hands and feet. Then once that pain went there was some tingling in hands, feet, and tongue. After that symptom didn't go away, she went to her doctor and was prescribed "Verapamil". Patient stated that medication did not work, then she started having more numbness and started feeling a skin crawling/ tingling sensations in her hands and her arms. Patient stated that there was some frazzled nerve feeling, then a numbness. Patient randomly has shocking/stinging sensations. Patient stated that she feels like her muscles are very weak, and she's been having some shallow breathing and some anxiety as well. She said the there is some slowness in her coordination, and balance. Recently, patient has been feeling like her blood circulation has been cut off several times a day (for about a second each time).