chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Complaints of cramping; dose number: 5; dose number: 5; Other vaccine same date vaccine date: 14Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 21:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose: 2; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 14Sep2022, outcome "unknown", described as "Other vaccine same date vaccine date: 14Sep2022"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 14Sep2022 at 21:00, outcome "unknown" and all described as "dose number: 5"; MUSCLE SPASMS (non-serious) with onset 16Sep2022 at 17:00, outcome "not recovered", described as "Complaints of cramping"; DIARRHOEA (non-serious) with onset 16Sep2022 at 17:00, outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea, muscle spasms.  Additional information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Adverse event: Diarrhea 2 days later around 5pm. Complaints of cramping on the day after that. She does take other medication, but I don't have a list. If treatment ae: No.  No follow-up attempts are possible. No further information is expected.
Dose 1 of twinrix in October 2020 / is late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient was late for 2nd dose of Twinrix and till the time of reporting, he did not receive it, which led to incomplete course of vaccination. The reporter asked, if the patient need to restart the series. No other details of vaccine available. The reporter consented to follow up.
12 hrs after shot, sharp pain in r side of head, Same in  heart. Could not sit up for 12 hrs, drank only cold water from caregiver.
Pfizer-BioNTech COVID-19 Vaccine EUA. Patient felt dizzy and had elevated blood pressure. Pulse normal.
My heart was racing; This is a spontaneous report from a contactable Consumer. This Consumer reported that:  A patient of unspecified age and gender received BNT162B2 (Comirnaty, Formulation: Solution for injection, Batch/lot number: Unknown, Expiry Date of Unspecified Vaccine: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date patient heart was racing (I 'only got the vaccine (Unspecified Vaccine) on Saturday and ever since Saturday I was having like my heart was racing. I was like I do not know (incomplete sentence). When again probed for the concern, Patient stated, "Is there anyone else I could speak to, maybe there is a language barrier, I think that is what the issue is. I can hear you. I asked if there is someone I can speak to where there is no language barrier. I was telling you something and you cannot understand me and you still cannot understand me. So is there anyone that I can speak to where there's not a language barrier. Limited information was available over the call. The clinical outcome event was unknown  Follow-up attempts have been completed and no further information is expected.
Patient fainted after receiving Tdap and HPV vaccines. She was sitting on exam table while nurse was finishing charting. Patient all of a sudden fell off table onto floor. Unable to arouse for 10-15 seconds. After we got her aroused she was placed on bed. She complained of nausea, sweating, and pale. Also hit on top of head, as shell fell to floor. Doctor notified.
I started having slight heart palpitations last week, and even the first night of my first dose I was having slight chest wall pain but that it went away.
Vaccinee states she develops itching at vaccine site on 8/7/2007. On 8/8/2007 she presents to Employee health.  Employee Health nurse notes erythema 4" X 2" at vaccination site, site is warm and hard over the red area, skin intact, still complaint of some itchy feeling.  Nurse advised to monitor, take anti inflammatory oral medicine, topical over the counter cortisone for itching as a personl choice.  Advised to report back to employee health if symptoms get worse.
Keratoconjunctivitis. Tx: preservative free artificial tears, no contact lens wear. 5-7 days.
HEADACHES/PAIN AT THE BACK OF THE HEAD AND BASE OF THE SKULL 3 EPISODES; MILD NAUSEA EXPERIENCED IT 4 TIMES LAST WEEK AND LAST NIGHT; INCREASED SALIVA/MEDIUM AMOUNT OCCURS DURING NAUSEA EPISODE ONLY; SWEATINESS OCCURRED ONLY AT NIGHT, STATED THAT SHE WOKE UP WITH A WET T-SHIRT IN A COLD SWEAT; CHILLS OCCURRED ONLY AT NIGHT AT THE SAME TIME AS THE FEVER; RIGHT ARM SORENESS; FEVER/FELT HOT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included diazepam, and fluoxetine hydrochloride. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6/10. On 01-APR-2021, the subject experienced increased saliva/medium amount occurs during nausea episode only. On 01-APR-2021, the subject experienced sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat. On 01-APR-2021, the subject experienced chills occurred only at night at the same time as the fever. On 01-APR-2021, the subject experienced right arm soreness. On 01-APR-2021, the subject experienced fever/felt hot. On 01-APR-2021, the subject experienced mild nausea experienced it 4 times last week and last night. On 03-APR-2021, the subject experienced headaches/pain at the back of the head and base of the skull 3 episodes. Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat, chills occurred only at night at the same time as the fever, right arm soreness, and fever/felt hot on 03-APR-2021, had not recovered from mild nausea experienced it 4 times last week and last night, and increased saliva/medium amount occurs during nausea episode only, and the outcome of headaches/pain at the back of the head and base of the skull 3 episodes was not reported. This report was non-serious.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose 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 (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-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 (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose 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.   The reporter was an internal medicine manager. Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Medication error- 16 year old Pt received a 1st dose of Moderna which is only licensed for 18 year and older
Pt has sore arm, muscle from deltoid muscle, up arm to shoulder and to back on shoulder blade since 7/25/20
2nd dose was given too soon.(1st dose was April 21st and 2nd dose was April 30th) Patient was observed for 45 minutes after vaccine given and no adverse effects were noted
Patient developed erythema at the injection site that continues to spread from the injection site down to the start of the fore arm  in large patches. The patient describes the area as itchy and non-painful.
temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 58 years old and unknown gender patient who experienced temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date there was a temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error).  On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as immunization.  On 22-SEP-2022 the vaccine was administered to the patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data; administered to patients with no reported adverse event, vaccine was adminstered to the patient with no reported adverse event).  At time of reporting, the outcome was Unknown for all  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient was intially responsive.. After waiting approximately 5 minutes patient informed staff at pharmacy that she felt like she was going to have a seizure. Patient moved to floor from chair. Was conscious for about 5 more minutes. Lost consciousness during seizure (approximately 2-3 minutes). Emergency medical personnel was called at that time. Patient regained consciousness and went with EMS to hospital for further testing.
It left her weak and tired; It left her weak and tired; Diarrhea; She was exhausted all day and all night, most exhausted she has ever been.; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 83-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: E19269), via an unspecified route of administration on 09Feb2021 (at the age of 83-year-old) at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 via an unspecified route of administration on 09Jan2021 (at the age of 83-year-old) at dose 1, single for covid-19 immunisation (She says they have the first dose written too but she had no side effects with the first dose. She can't make that lot number out either on the vaccine card it might be FL or EL3247). On an unspecified date in Feb2021 the patient experienced it left her weak and tired, diarrhea, she was exhausted all day and all night, most exhausted she has ever been. Reporter says she is 83, she will be 84 at the end of the month. She says she had the second shot yesterday and it left her weak and tired, she stayed in bed all day and she had diarrhea. Her second dose was yesterday 09Feb2021 and after she was exhausted all day and all night, most exhausted she has ever been. Product details: She says the lot number looks like E19269 or it could be FL but to her it looks on the vaccine card like E19269. It just says the date she got it which was 09Feb2021 and the first dose was 09Jan2021. Now that she has gotten 2 shots can they say if she can be out and about among people now or does she still need to stay isolated. She would like an answer to that because she had a chiropractor with no social distancing. He had 15-20 people all together in one room and actually he had her between 2 people in a massage chair and that chiropractor treated a patient and didn't wash his hands and he helped her but that night she had nightmares so she stopped going to him. She says with the diarrhea she was lucky to get home in time it was 20 minutes later, almost instant and she is fine today. She confirms everything is good today, she says when you sleep all day you have to be okay the next day. She would like to know if she can socialize now. She doesn't use a physician so there is no one to follow up with she is not sick, she is a healthy person, other than a chiropractor and he would not know. Events were reported as non-serious. Outcome of all the events was unknown.    Follow-up (12May2021): Follow-up attempts completed. No further information expected.
The patient also had a sore left injection site arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient also had a sore left injection site arm) and HEADACHE (Headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient also had a sore left injection site arm) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (The patient also had a sore left injection site arm) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-487475, MOD-2022-487384 (Patient Link).
I tested positive for COVID-19 1/2/23. I had cold symptoms and that is it. Not even a bad cold. I had congestion, deep cough, and fatigue. No other symptoms. The deep cough is what made me think I had more than a cold. I contacted my doctor to inquire about PAXLOVID, and he told me not to take it unless I had shortness of breath. So, I did not take it.
Patient experienced redness, itchiness and swelling at the injection site. Patient was asked to follow up with physician where she received prednisone 10mg and BENADRYL and asked to place cold compression on injection site.
Anaphylaxis beginning 1/2 hour after injection: Erythema, facial angioedema and increased asthma symptoms, sense of throat swelling, abdominal pain.  Prescripted Epi x1, albuterol and prednisone with resolution of symptoms.  Asthma symptoms continued over next 3 days.  No further problems.
DONOR RECEIVED SHOT WENT TO LOBBY TO WAIT REQUIRED 15 MIN, DONOR CAME BACK TO MSA OFFICE C/O OF DIZZINESS/LIGHTHEADEDNESS AND FEELING THAT EVERYTHING WAS TUNNELING IN, AND HEARING WAS MUFFLED. DONOR WAS ASSISTED TO BED TO LIE DOWN AND GIVEN ICEPACK AND FANNED AND DONOR RECOVERED QUICKLY.
TOOK THE DOSES WITH FOOD; TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1098) was received from a consumer on 03-May-2019. It describes an 18-year-old male consumer who "took unrefrigerated doses" and "took the doses with food", while being on Vivotif for an unknown indication.  Case report: The consumer took Vivotif doses with food. They were stored incorrectly. She stated that door of the refrigerator was open for at least 8 hours. She also had snacks within an hour before or after taking doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "took the doses with food" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "took the doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and also "took the doses with food" was considered as not applicable.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender, Medical history and concurrent conditions were not reported. On 11-MAR-2014, the patient was vaccinate with third dose of ROTATEQ oral, lot # J008735; expiration date: 24-MAR-2015 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-393534, MOD-2021-393535 (Patient Link).
This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On 22-MAY-2017, the patient was vaccinated subcutaneously in the left arm with an expired dose of VARIVAX injection (lot # L017145, expiry date: 13-MAY-2017; the dose was not specified). The concomitant medication included sterile diluent injection. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.