chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bexsero administered by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 13-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31-AUG-2022) for prophylaxis.   In MAY-2022, the patient received the 1st dose of Bexsero. In MAY-2022, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Bexsero administered by mistake). The outcome of the inappropriate schedule of vaccine administered 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: 05-MAR-2023 On the day of reporting, the patient attended the clinic and a medical assistant realized this patient should not had received the first dose of Bexsero last year, but by mistake they administered it.  Then, the same day (day of reporting), the patient received an MCV4 vaccine (MenQuadfi). The reporter asked if the patient needed a second dose of Bexsero. The reporter consented to follow up. The patient received the first dose of Bexsero last year mistakenly, which led to inappropriate schedule of vaccine administered.
1:35pm Post vaccination reports feeling nauseous w/no additional symptoms; medical monitoring w/vital assessment: BP 89/54 P69 RR 20 O2 sat 96% RA, rest, po hydration, snack. 1:50pm Reports feeling better w/no additional complaints, NAD,  BP 88/66 P88 RR 16.  Released from facility w/ self.
Patient woke morning after injection with flu like symptoms. Muscle aches, chills, headache, fatigue, low grade fever.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CITALOPRAM, start date: 30Apr2014. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient received treatment from 30Jul2022 to 03Aug 2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive, notes: I test positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This is pt's second vaccine. Headache, chills, shaking (Tremors) jaw pain and nausea. Also arm sore. Pt went to PCP, got a steroid shot and MD wrote fax for NSAIDs and BENADRYL. First dose SHINGRIX 2 months ago arm sore for 2 weeks.
chills; tiredness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced chills and tiredness. On an unknown date, the outcome of the chills and tiredness were unknown.   It was unknown if the reporter considered the chills and tiredness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced chills and tiredness after vaccination. The patient asked how long will the event last. The patient scheduled to fight tomorrow.
Approximately 5 minutes after patient received vaccination, the patient passed out.  He was standing outside the pharmacy and fell down.  Family member cried for help.  911 called. Once I got to patient, he was responsive.  Had patient sit up till paramedics arrived.   Patient did not go to ER.  Tried to call patient 2 days later to see how he was, but no answer.  Did not leave message.
About3 days after the second vaccination on Feb 4th, I started feeling unwell. I had respiratory issues. I went to the doctor on  Feb 15th 2021 and she diagnosed me with pneumonia after taking an x ray of my lungs. She prescribed a course of  Azithromycin anti biotics that cleared the pneumonia but I am still suffering from ongoing breathing issues
Patient complained of swollen neck, ear,  and jaw tendon. Wanted it to be reported. It happened about 5 days after she received the vaccine.
This spontaneous report as received from a pharmacist refers to a 56 years old non pregnant female patient with no drug reactions, allergies and no pertinent medical history. On 26-FEB-2014 the patient was vaccinated subcutaneously with ZOSTAVAX (dose 0.65 ml, once, lot # reported as J011548, expiration date reported as 19-DEC-2014). There were no concomitant medications. The pharmacist reported that after a patient was administered ZOSTAVAX (in approximately February 2014) she developed a bump the size of her hand, that was hard and hot to the touch at the injection site. There were no lab diagnostics studies performed. There was no treatment given for the events. The outcome of the event was reported as not recovered. The patient sought medical attention by calling the pharmacist. The relatedness between the event and suspect vaccine was not reported. Additional information has been requested.
Pt. states that after receiving the 1st dose of Phizer 01/24/2022, started experiencing symptoms 02/01/2022 of irregular heartbeat, chest pains, and shortness of breath. Emergency Room transport Hospital/ Admitted for Observation. EKG preformed = Normal/Blood Panel = Normal/Chest X-Ray =Normal/High Sensitivity Troponint = Normal. Symptoms have subsided. No noted Primary visit/communications. (Treating Physician) (Covid+ 01/04/2022)
w/in 72 hrs c/o nausea, loss of appetite, palms of hands red for short period; denies fever;
pt recvd vax & devel large areas of redness & swelling which were hot to touch on the arm following vax;
Pfizer 5/29 and 6/20. Positive on 12/17
pt reported burning @ site of inj rt deltoid;pain radiating to wrist, hand, & fingers w/in min of inj & later to back;deltoid muscle became swollen, inflamed w/ inc temp;seen by acute MD;
Left upper arm with 3x4cm area of blotchy/red, erythema and minimal swelling around injection site. No warmth of fluctuonce or pain to area. Redness initially noted about 0900 on 11/03/04 and per parent had not progressed in redness, swelling from 0900 to 1645 (time of exam). I felt this was a local reaction.
Muscle aches; Chills; Nausea; Headache; Soreness at the injetion site; Feels likke the flu; Coughing; Fever of 100.8°F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Feels likke the flu), COUGH (Coughing), PYREXIA (Fever of 100.8°F), MYALGIA (Muscle aches) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stones.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (Fever of 100.8°F). On 15-Apr-2021, the patient experienced INFLUENZA (Feels likke the flu), COUGH (Coughing), MYALGIA (Muscle aches), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injetion site). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency. At the time of the report, INFLUENZA (Feels likke the flu), COUGH (Coughing), PYREXIA (Fever of 100.8°F), MYALGIA (Muscle aches), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injetion site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 100.8°f (High) 100.8°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Boostrix was administered to a 2 year old patient inadvertently on 17Jul2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29-NOV-2024) for prophylaxis.   On 17-JUL-2023, the patient received Boostrix. On 17-JUL-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix was administered to a 2 year old patient inadvertently on 17Jul2023). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via mail. The reporter reported that a dose of Boostrix was administered to a 2 year old patient inadvertently, which led to inappropriate age at vaccine administration.
Nauseated and throwing up; Had been throwing up; A spontaneous report was received from a Consumer concerning a 69-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling nauseated/ nausea and had been throwing up/ vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 032l70A) in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced feeling nauseated and had been throwing up.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, feeling nauseated and had been throwing up was not resolved.; Reporter'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.
Developed three small ulcerative lesions surrounded by erythema and swelling on 3/2/03
Information has been received from a lawyer regarding a case in litigation concerning a male of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-MAY-2017, the patient was administered the ZOSTAVAX by a health care provider at a hospital (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider at a hospital for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Acute respiratory failure with hypoxia requiring hospitalization 2/2 to COVID-19 infection
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB with lot # M020926 and expiration date of 11-AUG-2018 and lot # M037248 with expiration date on 21-FEB-2019 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of 12 Centigrade degrees (°C) range for a time frame of 24 hours. The temperature excursion was recorded by a data logger and the previous excursions were reported as 9°C to 25°C for 9 hours for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014373: US-009507513-1704USA007701: US-009507513-1704USA014372.
Patient had 2 doses of Moderna COVID vaccine on 1/20/21, and 2/17/21, and was hospitalized for COVID respiratory failure from 12/3/21- 12/6/21
Right elbow redness soreness burning ,   right kneecap burning Pimples on left shoulder and neck area very itchy   right and left  wrist area pimples and itchy  FYI Elbow and wrist pimples had 2 small holes on each sore that almost looked like I was bitten by something but I wasnt. Dermatologist stated to apply Mometasone Furoate Ointment USP,0.1% which helped with the burning and itching.
He got vaccine done on a Saturday and by that evening had flu like symptoms and the next morning woke up with hives on his legs.
1/6/19 at 18:00, small patches of itchy rash on extremities. No treatment. 1/7/19 at 01:00, extremely  itchy, tingling rash/hives wrapping around entire trunk, all extremities and back of scalp, but no rash on face. Minor swelling of extremities. Also, small lumps (not painful, just raised bumps) in mouth. No actual difficulty breathing, but presence of slightly irritated sensation in bronchioles when breathing. Treatment beginning 1/7/19, diphenhydramine HCl at approx 01:20, 50 mg; 03:30 additional 25 mg; 08:00, 50 mg; 12:30, 50 mg; 15:20, 25mg; 18:30, 50 mg; 22:30, 50 mg. Patches of rash still present on trunk and extremities, somewhat less itchy. 1/8/2019, diphenhydramine HCl at 02:00, 50 mg, 07:00 50 mg. Minor rash throughout, getting less itchy. Bronchioles no longer feel irritated and small bumps in mouth have gone away.
Nausea, vomited at 315 am and again on 3/13 at 10pm stomach ache
Patient stated that after getting the shot she never received a menstrual cycle. She went to the DR. and they ran a lot of test.  Patient stated that she was not in or near the menopause stage.
Severe and persistent  Joint pain  (knees, elbows, wrists, fingers etc.), chills, slight headache and back pain 14 hours after administration.  Symptoms still continue 23 hours later.  Fatigue as well.
PATIENT HAD REDNESS AND SWELLING DOWN THE LEFT ARM WHICH WAS THE ARM SHE GOT BOTH THE FLU VACCINE AND PNEUMONIA VACCINE.
4 x 4 cm red, warm edematous area at injection site on left arm (ADACEL).
Pressure on chest; Respiratory allergies; swollen right hand; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration in the right arm on 25Feb2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies and food sensitivities. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR) and lansoprazole (PREVACID); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 via nasal swab COVID-19 on 08Jul2020 with negative result and on 07Jan2021 with unknown results. The patient experienced pressure on chest, respiratory allergies and swollen right hand on 26Feb2021 at 10:30 PM. The patient was treated with diphenhydramine hcl (BENEDRYL) for the events, pressure on chest, respiratory allergies and swollen right hand. The outcome of events, pressure on chest, respiratory allergies and swollen right hand was recovering.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
PATIENT STATED SHE WAS COVID POSITIVE 1 WEEK AFTER RECEIVING INJECTION.
Indurated, inflamed site of injection with pain spreading to (L) ribs, breast and axilla.
hives, shortness of breath, vomiting, sweating,dizziness, rapid heart beat, swollen throat
Grandparents stated temp was 106; pt stated saw snakes was trying to keep then off; taken to ER;
Lymphadenopathy around armpit; Dose Number: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp).   A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 16Dec2021 at 14:00 (Lot number: unknown) at the age of 25 years as dose number 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS and "Clinical depression" (unspecified if ongoing). Concomitant medication included: LEXAPRO. Past drug history included: Lamotrigine, reaction: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: intramuscular), administration date: an unknown date in Mar2021, when the patient was 25 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown, Route of administration: intramuscular), administration date: an unknown date in Apr2021, when the patient was 25 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 14:00, outcome "unknown", described as "Dose Number: 3"; LYMPHADENOPATHY (non-serious) with onset 19Dec2021, outcome "recovering", described as "Lymphadenopathy around armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; lethargy, very high T, local large swelling & redness;
Rash started over band aid and spread all over body. Was with fever. Questionable allergic reaction or viral exanthem.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Received Moderna Covid19 vaccine on 1-20-21. On 1-21-21 developed headache, chills, fever, redness at site of injection. It measured 3"x2". Temp reached 101.9. On 1-22-21 woke to a headache but fever is gone. Site of injection redness appears the same itchy.
INITIALLY COMPLAINED OF HEAD HURTING A LITTLE AND SLIGHTLY DIZZY.  5 MINUTES LATER COMPLAINED OF THROAT AND CHEST FEELING TIGHT AND DIFFICULTY BREATHING.  DOSED WITH EPI AUTO INJECTOR X 2 AND BENADRYL IM 100 MG AND SHE WAS TRANSPORTED TO ER FOR EVALUATION.
fatigue; headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (low grade fever) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 15-Feb-2021, HEADACHE (headache) had resolved. On 17-Feb-2021, PYREXIA (low grade fever) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 98.3 (normal) 98.3.         No concomitant products were provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI-No new information
pt recv vax 9JUN95; next day pt started w/high pitched cry for 45mins to 1 hr, arches back-doesn't cry all noc but most of the time; pt does calm w/bottle; called ofc on 15JUN95 pt crying constantly; t98.8 15JUN95;
Steady increases  of injection site pain, inflammation, and redness. Left bicep is swollen up to twice normal size and affecting nerve, with tingling pain from tip of fingers to teeth on left side. Lymph node under left armpit is also very swollen, painful. Mild body itching with widespread inflammation. Progressive since time of injection despite use of NSAIDs and Benadryl