chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired dose of Bexsero to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 20th June 2022) 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 15th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 15-JUL-2022 Reporter's Comments: The case was reported by the medical assistant. Reporter administered an expired dose of Bexsero to the patient. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Patient complained of pain during injection. It was the "usual sore for the next 48 hours" "I have had no previous shoulder injury. The pain is persistent, and is a deep, non-muscular pain that affected my range of motion. It is painful to move my arms to put on and take off clothing, cooking, and even completing my normal work. I have no signs of infection. On Thursday night, 5-30-19 , the throbbing, constant pain was so intense, I told my husband that something must be wrong, as the pain was a 9/10 and I was sobbing. I began to search the internet for shoulder pain from vaccines. I eventually found Shoulder Injury Related to Vaccine Administration (SIRVA). Based on my symptoms and time interval of symptom onset, it appeared that this is what was going on in my shoulder. SIRVA is a reportable event following vaccination according to the Vaccine Adverse Event Reporting System.
Client was vaccinated with Pfizer vaccines on 4/11 and 5/11/2021.  Developed Covid symptoms on 11/21 - nasal congestion, cough, fatigue, headache.  Tested + 11/24 for Covid with PCR.
dizziness, sweating, headache, numbness in arms.  given 25mg diphenhydramine liquid and water.  he did not pass out but felt as if he might.  he rested in the waiting area until he felt he could leave safely on his own (about 30 minutes).
Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a female customer (age not reported) who on an unspecified date was vaccinated with a flu vaccine (manufacturer unspecified) and "your company's" PNEUMOVAX23 and had an adverse reaction. (The date of vaccinations was not specified). The "date of loss" was reported as 29JAN2014. No details were provided. Treatment and outcome of adverse reaction was unknown. Additional information has been requested.
Came to office - pt with symptoms of S/A, sitting around, and redness with edema to right thigh. Saw per PNP and Dx with cellulitis (local reaction to immunization).
In 2021 I was early in my pregnancy when I received my first shot. I didn?t know I was pregnant at the time. I found out a few days later. I miscarried on 3/22/21. We attempted again to have a baby in 2022. I was pregnant for a few weeks in March of 2022 but also miscarried on 3/27/22.
Diarrhea sharp pain on the left side of the temple of my head, and head ache loss of appetite for a day localized pain near injection site on left arm (expected and not too bad)
Within 3 hours of PNEUMOVAX administration patient developed erythema, edema and pain at injection site.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 28-year-old female 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 administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because facility was unable to download the digital data logger, they would need to treat the 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 that time. It was reported that no adverse reactions were reported by the patient.  No treatment information was reported.
01/26/04: 10 days after administering varicella vaccine, he developed a small cluster of tiny papules  on erythematous base at site of injection.  No pruritis/discomfort.  Treatment: Ibuprofen with ice.  01/29/04: Still there.  No master change.  Urticarial hardness at base.
Patient came in for 2nd Shingrix shot but was given Moderna Covid shot instead.  Pharmacist realized mistake after and patient was then given the Shingrix shot as well.
Vaccines administered after 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 (Vaccines administered after temperature excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) in a 0-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after 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 (Vaccines administered after temperature excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after temperature excursion) and PRODUCT STORAGE ERROR (Product Storage Error).    No concomitant medication information was reported. The vaccines administered after temperature excursion. 20 doses were administered of bivalent Moderna COVID-19 vaccine after this excursion on 15DEC2022. No treatment medication information was reported.
NA Comfort Cares-acute hypoxic respiratory failure in the setting of bilateral pulmonary extensive infiltrates due to ARDS, pneumonia and possible component of CHF exacerbation. Non-ST elevation myocardial infarction.
Patient was given Pneum. 23 vaccine on 02/11/05. On 02/1305, a call was placed to fellow on call, reporting a swollen arm (tennis ball size), vomiting and low grade fever. Patient was sent to ER where he was given Keflex and discharged.
Severe body aches; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06May2021 at 11:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and migraine. The patient previously received chlorpromazine (THORAZINE) and infliximab (REMICADE) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for an unknown indication, from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 at 11:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 07May2021 at 06:30, the patient experienced severe body aches, headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe body aches, headache and fever was resolved on 07May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed an arrhythmia after the fifth dose. My pulse has run at times as high 180 BPM. My blood pressure also doubled. Before I got the fifth dose, my pulse was normally in the 60s and 70s. Before the fifth dose, my BP was in the neighborhood of 120/70. Since developing these symptoms, I have been prescribed CARDIZEM (120 mg three times a day), ELIQUIS (5 mg twice a day), flecainide (50 mg twice a day). Since taking the medications, I have been halfway stable.
Twitch in right quadricep for 24 hours, onset 12 hours after vaccine Noticeable decrease in breast milk supply at 3.5 mo post partum; 40-60% decrease lasted for 10 days; normally pump 5 oz 2x/day (morning and night); instead, was only able to pump 2-3 oz 2x/day. Supply began to decrease within 24 hours of vaccine.
Within a few hours of vaccine she began to have a very sore arm and headache.  Around 1:00 A.M. on 04/09/2021 she began having chills and joint pain, but no fever as the headache continues.  The event that concerns us was she began to have tingling in her fingertips  both hands.  This has been going on since 1:00 A.M.  Her NP was notified and they said to watch it over the next few days and report to CDC/ FDA.  Patient had Covid December 24, 2020.  We waited the 90 days to get vaccinated and had clearance from her doctors.
This spontaneous report received from a registered nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The nurse reported that on 14-MAY-2015, the patient wad inadvertently vaccinated with 0.5 milliliter (ml) of ZOSTAVAX subcutaneously. (Product, lot#, expiry date not reported). No adverse effects was reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information is not expected as there was no consent to contact the reporter.
Denies any problems with vaccines.  Patient states that her provider gives her the High Dose Flu vaccine because she gets pneumonia easily and because of her health problems.  I explained that we do not give it before age 65 and that is why I am making this report.  She did not feel that there were any adverse effects.
roughly 10min p/all 3 vax pt felt dizzy & fell on floor from standing position; VS were stable;BP 100/70;pulse 110/min;RR20;pt was taken by amb to hosp in
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 20-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K004394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
rxn @ site of inj w/vesiculation;topical steroid cream; resolved;
2000 Light sensitivity 2200 cold/shakes 2430 nausea  0300 vomiting, fever 102.3
Information has been received from a registered nurse concerning a 13 year old white male with no medical history who on 08/16/1996 was vaccinated subcutaneously in the right arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  There was no concomitant medication.  Subsequently the patient developed approximately 20-30 pox lesions after his brother with the same symptoms.  There were no relevant diagnostic tests or laboratory data.  The outcome was reported as recovered.  Additional information has been requested.
elevated CA125; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via medical information team. A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date in Apr2021 as single dose for COVID-19 immunisation. Medical history included ovarian cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient experienced elevated ca125 (carbohydrate antigen 125 increased) on an unspecified date. The patient had blood test and the patient was asking proteins cause elevated CA125. She indicates the concern as test results from protein. Indicates being sent for a PET scan. The outcome of event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Patient passed out immediately after the vaccination. He appeared to have a seizure for 1-2 minutes. His mother referred to it as a vasovagal response.
Contraindication to vaccine.   Vaccine licensed for 2-49 yrs old.
Patient reports redness and swelling that began the night of immunization. Patient had symptoms for 3 or 4 days.
Information has been received from a physician concerning a nursing student who on an unspecified date was vaccinated with a dose of MMR II (Lot#: not reported). The physician stated that the nursing student had had titers drawn prior to admission to nursing school. The titers were not at an acceptable level. At the time of the report the patient's status was unknown and it was unknown if the patient sought medical attention. Follow-up information was received from the physician who stated that no patient had a reaction to MMR II. No further information is available.
covid vaccine breakthrough case  dose 1 Moderna 2/26/21 010A21A dose 2 Moderna 3/25/21 030A21A
Area at site of injection is red, edematous, warm to touch, raised, and patient reports the skin around the area itches.
Pt had poor appetite, slept most of the day, on 7Dec90 high pitched cry while sleeping, no fever, on 8Dec90 inconsolable crying for 2-3 hrs, taken to ER, Dx /w "gas"
arm was hurting; pinpoint headaches; like a pressure in a couple of places; Now it is starting to hurt again like it was earlier; it keeps hurting in certain areas; Numbness in hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), HEADACHE (pinpoint headaches), HEAD DISCOMFORT (like a pressure in a couple of places), HYPOAESTHESIA (Numbness in hand) and PAIN (Now it is starting to hurt again like it was earlier) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ATORVASTATIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), MAGNESIUM and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in hand). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was hurting), HEADACHE (pinpoint headaches), HEAD DISCOMFORT (like a pressure in a couple of places), PAIN (Now it is starting to hurt again like it was earlier) and PAIN (it keeps hurting in certain areas). At the time of the report, PAIN IN EXTREMITY (arm was hurting), HEADACHE (pinpoint headaches), HEAD DISCOMFORT (like a pressure in a couple of places), HYPOAESTHESIA (Numbness in hand), PAIN (Now it is starting to hurt again like it was earlier) and PAIN (it keeps hurting in certain areas) outcome was unknown. Not Provided          No  Treatment History was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Significant follow up appended. On 20-May-2021: TCR: outcome of AE
Patient stated she recieved the vaccine on Tuesday 4/13/21 @830am and a few days later she started to experience redness on right arm and swelling/soreness, hot to touch. No fever, body aches, or chills, sob or chest pain. Patient stated she took Tylenol (taken on 4/21 at night and on 4/22 in am) and Claritan and neither helped, she also placed an ice pack on arm and it helped with the hotness but not with the swelling. On 4/22 in am patient also took Loratadine.   Patient has PCP appt on 4/28/21 for other reasons but if symptoms continue she will let PCP know. Advised patient that she can continue with Tylenol or she can take Ibuprofen, also recommended that she can take Benadryl or apply Benadryl cream/Hydrocortisone to help with the itchiness. Also advised to continue applying the ice pack to help with the hotness and informed her if she feels her arm is getting worse and swelling is not subsiding then to see her pcp as soon as she can. Will follow back up on Monday 4/26 to see if symptoms subsided. Called pt 4/26 and 4/27- no answer
Dizziness, migraine, blurred vision. On 12/20/02 had vomiting and diarrhea. Could not drink water or keep anything down. Severe abdominal cramping. *Follow-up report received on 2/5/03: Vomiting, diarrhea, abdominal cramping, migraine headache, blurred vision, dizziness, couldn't keep down or keep water in stomach for 24 hrs.
Dizziness and weakness, injection site pain, tenderness, swelling, redness, fatigue, headache, muscle pain, joint pain, severe chills started on Thursday, July 8 early evening and ended on Friday evening around 11:30 p.m. , had a fever that lasted the same amount of time.  Side effects started on Tuesday, July 6, 2021.   Injection on July 3, 2021 later in the afternoon pain from shot in the left arm, joint pain and redness occurred that night.   On Wednesday, July 7, I started taking Ibuprofen 200 mg every 4 hours until Saturday, July 10, 2021.  Symptoms seemed to be gone late Saturday night, July 10, 2021.
He developed increased fussiness and abnormal stools with blood/mucus.  Was instructed to go to the ED.  He went to  ED and had an US which showed "Self resolving intussusceptions noted during the exam, this is likely intermittent small bowel intussusception. "
Patient received a Moderna Booster today to early. Her second dose was 10/01/2021. Pt has no signs or symptoms of any adverse reaction. Pt was observed for 15 mins after vaccination with no complaints. Dr. (NAME) notified and reports no concerns for pt. The HCF has already established new protocols to ensure this does not happen to another again.
Patient received moderna vaccine on 2/3/21, 3/3/21, and 1/11/22. Presented to ER and found to be covid positive on 4/24/22. presented to the emergency department secondary to weakness.  He was unable to get out of his chair.  In the emergency department was found to have a fever which resolves after admission and did not recur and also a little bit of hypoxia with activity but otherwise not requiring oxygen.  He was COVID positive.  In light of the above factors was admitted for observation and close monitoring.  Was started on remdesivir and dexamethasone.  Was on oxygen for the next 24 hours per protocol but by the time of discharge was not requiring it at all.  He remained comfortable with minimal coughing.  Was ambulating at his baseline by the time of discharge.  Felt at his baseline so was discharged home in stable condition. Discharged on 4/26/22