chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: 1805USA009899:Original Case : 1805USA006787; 1805USA009900:Original Case : 1805USA006787; 1805USA009901:Original Case : 1805USA006787; 1805USA009902:Original Case : 1805USA006787; 1805USA009903:Original Case : 1805USA006787; 1805USA009904:Original Case : 1805USA006787; 1805USA009905:Original Case : 1805USA006787; 1805USA009906:Original Case : 1805USA006787; 1805USA009907:Original Case : 1805USA006787; 1805USA009908:Original Case : 1805USA006787; 1805USA009909:Original Case : 1805USA006787; 1805USA009910:Original Case : 1805USA006787; 1805USA009911:Original Case : 1805USA006787; 1805USA009912:Original Case : 1805USA006787; 1805USA009913:Original Case : 1805USA006787; 1805USA009914:Original Case : 1805USA006787; 1805USA006787:Original Case : 1805USA006787; 1805USA009916:Original Case : 1805USA006787; 1805USA009917:Original Case : 1805USA006787; 1805USA009918:Original Case : 1805USA006787; 1805USA009919:Original Case : 1805USA006787; 1805USA009920:Original Case : 1805USA006787; 1805USA009921:Original Case : 1805USA006787; 1805USA009922:Original Case : 1805USA006787; 1805USA009923:Original Case : 1805USA006787; 1805USA009924:Original Case : 1805USA006787; 1805USA009925:Original Case : 1805USA006787; 1805USA009926:Original Case : 1805USA006787; 1805USA009927:Original Case : 1805USA006787; 1805USA009928:Original Case : 1805USA006787; 1805USA009929:Original Case : 1805USA006787; 1805USA009930:Original Case : 1805USA006787; 1805USA009931:Original Case : 1805USA006787; 1805USA009932:Original Case : 1805USA006787; 1805USA009933:Original Case : 1805USA006787; 1805USA009934:Original Case : 1805USA006787; 1805USA009935:Original Case : 1805USA006787; 1805USA009898:Original Case : 1805USA006787.
body aches; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002AZIA) 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. On 15-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
administered frozen dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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: 19-MAY-2022 Reporter's comment: The licensed practice nurse (LPN) reported having administered a frozen dose of Bexsero. The adverse event report contained all information provided by LPN at this time. The LPN gave consent for safety to follow up.  The reporter consented to follow up. Additional supportive information: The nurse administered a frozen dose of Bexsero, which led to incorrect storage of vaccine. This case has been linked to the case US2022081277, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081277:Same reporter
This is a spontaneous case, initially received from other non-health professional on 12-Jan-2018, concerning a 34-year-old adult female pregnant patient. The patient had a history of 2 pregnancies. The patient's last menstruation date was 30-Jun-2017. No history of miscarriage in previous pregnancies. The patient had no history of major congenital anomalies and birth defects in previous pregnancies. The patient had no relevant maternal medical history relevant to pregnancy. The patient had no relevant paternal medical history. On 11-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) at 28 weeks of pregnancy. The EDD (estimated date of delivery) on 06-Apr-2018. The reporter considered this case as non-serious.
First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022; No adverse event; patient received expired first primary Monovalent Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired first primary Monovalent Moderna COVID-19 vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 055A22A and 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired first primary Monovalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired first primary Monovalent Moderna COVID-19 vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received expired first primary Monovalent Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022).    No concomitant medication details was reported. Intact cartons was used and vial size was 2.5ml. The vial was initially stored in the refrigerator on 06-JUL-2022. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Kidneys were also hurting too; burning sensation; OFF label use; she had heaves for a little bit; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation), RENAL PAIN (Kidneys were also hurting too), OFF LABEL USE (OFF label use) and RETCHING (she had heaves for a little bit) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (lot number 025520-2A) on 07-Jan-2021, COVID-19 Vaccine (lot number 008C214) on 19-Oct-2021 and Flu shot 1 week ago; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (lot number 029L20A) on 08-Feb-2021 and Moderna bivalent (lot number AS7165B) on 05-Oct-2022. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 vaccine, Flu shot 1 week ago, Moderna COVID-19 vaccine and Moderna bivalent.    On 02-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced OFF LABEL USE (OFF label use). On 02-Nov-2023 at 8:00 PM, the patient experienced BURNING SENSATION (burning sensation). On an unknown date, the patient experienced RENAL PAIN (Kidneys were also hurting too) and RETCHING (she had heaves for a little bit). At the time of the report, BURNING SENSATION (burning sensation), RENAL PAIN (Kidneys were also hurting too) and RETCHING (she had heaves for a little bit) had resolved and OFF LABEL USE (OFF label use) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had no medications or treatments taken. She felt like she needed to get an antiacid pill and also felt that her symptoms were due to the quantity of dose that she received.
fever/Fever 101 degrees Farenheight; chills; body aches; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever/Fever 101 degrees Farenheight), CHILLS (chills) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (fever/Fever 101 degrees Farenheight), CHILLS (chills) and MYALGIA (body aches). In February 2021, PYREXIA (fever/Fever 101 degrees Farenheight), CHILLS (chills) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101 (High) Fever 101 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Treatment medications was not provided.  It was reported that all symptoms lasted for 1 day.    This case was linked to MOD-2021-368894 (Patient Link).
Severe swelling, hard knot, warm to the touch   This occurred 10 days after the vaccine was administered. I have also had a tingling feeling in my arm and it painful!  At the guidance of the nurse and pharmacist, I have put hydrocortisone on the site and taken Benedryl and Tylenol. I?ve also used a cold pack.
Male received the Moderna Covid 19 vaccine 1st dose on March 17,2021. The 2nd dose of Moderna vaccine was administered  on 3/24/2021 instead of April 15. 2021 by RN.
pt recvd Engerix-B 25JUL91?, 26OCT91, & 30MAR91? & pt did not seroconvert; a booster dose is scheduled;
911 was called, patient symptoms were pale, weak, dizzy, nausea, headache and blurred vision. ER notes stated normal EKG, released with diagnosis of "possible reaction to flu shot."
8 days after shot I developed a large itchy rash on injection arm. It was sore to the touch.  It?s now 5 days later and still have rash although a lithe bit better with no soreness.
Information has been received from the Merck pregnancy registry from a registered nurse concerning a 24 year old female with no allergies and a history of gestational diabetes, who on 12-DEC-2006 was vaccinated IM with a first 0.5 ml GARDASIL (lot# 653978/0955F). Concomitant therapy included prenatal vitamins. The nurse reported that the patient received the dose while pregnant. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the patient was placed on iron for anemia on 18-JUN-2007. Subsequently, the patient experienced gestational diabetes. Laboratory examination included a 3 hour glucose test and the patient was placed on a 1800 calorie "APA" diet with accuchecks five times a day. It was reported that the patient delivered a normal baby girl weighing 7 pounds and 8 ounces on 24-AUG-2007 at 38.5 weeks gestation. The patient was 21 inches and had a head circumference of 34.5. It was reported that the patient had a improved apgar score (2/6/7). Other complications included a "body cord." Additional information is not expected.
My skin has hives; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Left arm, Manufacturer unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 26Apr2022, outcome "unknown", described as "My skin has hives"; PRURITUS (non-serious) with onset 26Apr2022, outcome "unknown", described as "itching".  Additional information: No covid prior vaccination. No covid tested post vaccination.  The lot number for the vaccine BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.
approx 3yrs p/vax pt exp 8-10 lesions noted as itchy, scabbed & 2 blistered
Plugged ears; Arm hurts; Shoulder is soring; High fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN at a dose of UNK UNK, q8h. At the time of the report, EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 100 (High) 100 degree F to 101.9 degree F. On 17-Jan-2021, Body temperature: 101.9 (High) 100 degree F to 101.9 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-Jun-2021 and contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Prevnar 13 administered on 7/22/2019.   Patient presented back at pharmacy on 7/29/2019 whith redness and warmth around injection site on right shoulder.   Patient reported no pain or discomfort just wondering if there was anything she could do.  Advised patient they could use tylenol/ibuprofen, benadryl, ice packs, and if doesn't get better or worsens to see their primary care physician.
hives, dizziness, flushing. Treated with antihistamine and steroids.
The caller stated there was localized induration that occurred  2.5-5.5cm with itching that occurred on 10/03/2022 at the injection site after the administration; itching that occurred on 10/03/2022 at the injection site after the administration; This spontaneous report has been received from a nurse prescriber (reported as health care professional) (HCP) concerning to a 26-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included allergy to previous aspirin. No other allergies or previous drug reactions were reported.Concomitant medications included norethisterone (NORETHINDRONE [NORETHISTERONE]).  On 24-SEP-2022(also reported as 02-SEP-2022,conflicting information)the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously (strength, dose, vaccination scheme frequency and anatomical location were not provided; lot number W005208, that was verified to be valid with an expiration date reported and established as 14-FEB-2024) for immunization against varicella; in combination with sterile diluent solution for injection/infusion(dose not reported)(lot number W003337, that was verified to be valid with an expiration date reported and established as 06-JAN-2023).  On 03-OCT-2022, the patient experienced a localized induration that occurred 2.5-5.5 centimeters (cm) (vaccination site induration) with itching at the injection site after the administration (vaccination site pruritus). By the reporting time the outcome of the events was reported as not recovered.  It was reported that the patient sought for medical attention, treatment was not received, and none laboratory diagnostic or studies were performed.  The action with varicella virus vaccine live (oka/merck) (VARIVAX) regarding the events, was reported as discontinued, however per internal guidelines, was assessed as not applicable.   The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX), and the events, was not provided.
Information was received from a field employee, who reported that a clinic administrator spoke on behalf of the physician, regarding an 81-year-old female. On 28-SEP-2010, the patient received PNEUMOVAX 23 (syringe PRF 25 Y), 0.5 mg, via injection, for the treatment of pneumococcal disease. On 29-SEP-2009, the patient experienced pain in her upper-left extremity (injection site), non-specific whole body pain and vomited after receiving the injection. Her shoulder became dysfunctional but was moving properly. On 01-OCT-2010, during a follow-up visit, the patient was assessed with cellulitis and an "abyss" at the injection site at which time the patient was treated with SEPTRA-VID. The patient's symptoms were still not resolved, so her arm was put in a sling. On 28-OCT-2010, the patient went to the emergency room complaining of "flamk." She underwent a chest x-ray for possible pneumonia (results not specified) and also had elevated liver function. She was released the same day from the emergency room (ER). The patient was not recovered. The events were considered disabling/incapacitating by the reporter. Additional information is expected.
burning in her legs from the knee down/burning sensation in her left thigh/Intermittent burning sensations throughout her body in different spots; lower lip has intermittent numbness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 12May2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that since receiving her Pfizer-BioNTech COVID-19 vaccine on 12May2021. On 13May2021, she woke up with burning in her legs, from the knee down, that went away. Then she got a severe burning sensation in her left thigh. She reports that the burning sensation was ongoing but describes it as "Intermittent burning sensations throughout her body in different spots". She also reports her lower lip has intermittent numbness. The outcome of burning sensation (PT) was not recovered while for other event was unknown.  Information on the lot/batch number has been requested.
Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similar -especially when removed from outer packaging. Medication error
Vaccine was given in the left under arm in the fatty tissue on tuesdat at @11:15am. 5 hours later the arm began to swell, turn red & hot and very painful.  Continued to get worse and was unable to sleep well that night[Tuesday]. Next day[Wednesday] swelling covered larger area, still hot & red.  The pain was so sever that I was unable to move my arm at all.  Called the doctor.  Never returned my call until the next day [Thursday]. I was told to take ibuprofen and apply ice.  Friday, arm still swollen, hot and red, only not as bad and pain less sever. Saturday,no reddness, slight swelling, no pain, but tender to the touch.  In hind-sight I should have went to the emergency.
elevated blood pressure; headache for less than a day; This spontaneous case was reported by a physician and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure) and HEADACHE (headache for less than a day) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Premature ventricular contractions (Premature Ventricular Contraction) on 01-May-2009. Concurrent medical conditions included Allergy to intravenous contrast media (Allergy to IV contrast) and Shellfish allergy. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) from 01-May-2009 to an unknown date for Premature ventricular contractions, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FISH OIL and PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache for less than a day). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure). On 05-Feb-2021, HEADACHE (headache for less than a day) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 120/75 (normal) 120/75.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported elevated blood pressure for 2 to 3 weeks, however none of the other symptoms. His blood pressure came to normal several weeks later. No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-004203 (Patient Link).