chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial opened in excess of recommended 12 hours.  Vial was opened on 12/8/21 at approximately 11:40 am.  Dose was administered on 12/9/21 at 9:29am.   No adverse effects have been reported.
Patient was given Havrix 1mL (19 years of age and up) instead of Havrix 0.5mL ( 12 months thru 18 years).  Patient has not experienced any adverse reactions from this.
11:00 patient received injection needed to sit for 30 min due to history - 7 mins after injection, patient nodded off and closed eyes, respirations were  watched, after 20 mins patient started to slump in chair, checked by nurse, patient stated "I just want to lay down I'm really tired, wife and nurse repositioned patient on side to sitting position, doctor notified, doctor assessed asked for glucose - 167 - BP 150/76, doctor recommended going to ER, patient stated I am tired and had a headache, blurred vision since yesterday" advised to go to er for ct,  wife and nurse placed in wheelchair, and assisted 2 person to private vehicle refused ambulance - wife stated that she would go to ER.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chemotherapy (in 2011) and radiation therapy (in 2011). Previously administered products included ZOSTAVAX. Concurrent medical conditions included breast cancer. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced fever, tiredness and chills. On 18th May 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the fever, tiredness and chills to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The patient reported that about 24 hours after receiving SHINGRIX, she experienced the reaction which was described as fever (101 degree F), chills and shivering. These symptoms resolved in 2 to 3 hours. The patient also felt a little wiped out in the evening. The patient did not have the paperwork nearby to see if she had a record of the lot number and expiry date of vaccine.
ITCHINESS; REDNESS OF ARM; SORENESS OF THE ARM; SWELLING OF THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problem, mild asthma, sinusitis, seasonal allergies, alcohol use, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use and the patient had bad allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced soreness of the arm. On 04-MAR-2021, the subject experienced swelling of the arm. On 04-MAR-2021, the subject experienced tiredness. On 04-MAR-2021, the subject experienced redness of arm. On 05-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness of the arm, swelling of the arm, tiredness, and itchiness, and the outcome of redness of arm was not reported. This report was non-serious.
Breakthrough COVID-19 case: I started to have a raspy cough, fever of 99.1 and fatigue. That evening I took two TYLENOL. I took two TYLENOL at 12:00AM, 04:00AM, 9:20AM. It took a home rapid test and it was negative. I continued to take two TYLENOL every 4 hours. On 05/23/2022 I had a tele visit with my doctor. She advised it sounded like I had COVID-19. I tested again and it was very positive. I was prescribed PAXLOVID, codeine and ibuprofen. My fever had gone up 100.4. After 10 hours my fever broke to 98.2. I rotated taking TYLENOL and ibuprofen every four hours. I still experience fatigue and a dry cough. On 05/28/2022 I tested again and it was slightly positive. I tested again on 05/30 and 05/31 and it was negative both times.
FEVER OF 101.3, SEVERE HEADACHE, CHILLS,  INABILITY TO SLEEP LASTING FROM 2AM UNTIL 7AM
Heart palpitation, once to three times a day. I have yet to see a doctor since I am currently working in another city. I am planning to see my doctor back in Oxford during the spring break, March 15.
Around the end of April, I started out with what felt like a sinus infection. Then a cough started. I was taking Mucinex to help with symptoms. As the week went on, I developed a sore throat and it moved into my lungs. I started feeling shooting pain in my chest and I started having a bit of difficulty breathing. I also had really bad fatigue. I went to a local care spot. They took an x-ray and told me that it was a lung infection. They prescribed steroids and antibiotics. It took about 5 days to resolve.
Coughing; chills; aches; This is a spontaneous report from a non-contactable other hcp (patient). A 25-years-old male patient received BTN162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9767), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not received any other vaccine in four weeks. On 18Feb2021, at 12:00, the patient experienced coughing, chills and aches. Patient did not receive any treatment to the events. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Very large swollen lymph nodes near clavicles on both sides (left and right); This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in May2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On an unknown date in Jul2021, the patient experienced swollen lymph nodes near clavicles on both sides (left and right). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes near clavicles on both sides (left and right) was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
5 days of fever up to 103 degrees with extreme irritability, poor feeding, unconsolable crying, very, very irritable.  Diagnosis-- probable vaccine reaction.
fatigue, severe headache, cough, dizziness, arm pain (injection site), fever (101.9), chills, joint pain, nausea, swelling of lips, feeling unwell overall.  Woke up at 1:15 a.m. with these issues.  Headache and fatigue remains at 8:21 a.m. this morning (8/21/2021).  Fever has  resolved. (First two Pfizer shots, I had fatigue and injection site pain lasting only a few hours.  This 3rd shot is far more problematic.)
Information has been received from a pharmacist via (PDC) referring to a 62 year old male patient. The patient had diabetes and hypertension. Concomitant medications included glimepiride and insulin. On an unknown date, the patient started vaccination with PNEUMOVAX 23 0.5 mL (route, lot # and expiration date unknown) for "an unknown indication based on his age". On 17-SEP-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (0.5 mL, lot # L019836, expiration date 24-MAR-2017; route was not provided) (expired vaccine used). Relevant laboratory data was unknown. As of 17-SEP-2017, it was unknown if the patient would receive PNEUMOVAX 23 again and the outcome of the receiving PNEUMOVAX 23 that had expired was unknown. During this report, the patient's other medications also included bupropion hydrochloride (WELLBUTRIN), Lisinopril (manufacturer unknown), metoprolol succinate (TOPROL XL), pantoprazole sodium (PROTONIX) and gabapentin.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. No medical history was reported. On 11-MAR-2014 the patient was vaccinated with the expired dose of PNEUMOVAX 23 (lot # H013399, expiration date 07-MAR-2013) (dose, route were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
pt recvd vax & devel local swelling; pt exp also "ulnar nerve" pain; pt also had pain when moving arm;
Runny nose, sore muscles, sore shoulder, swollen glands 11 days continuously after vaccine.
inadvertently administered Kinrix; inadvertently administered Kinrix; 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-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2023) for prophylaxis.   On 16-OCT-2023, the patient received Kinrix. On 16-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Kinrix) and inappropriate schedule of vaccine administered (Verbatim: inadvertently administered Kinrix). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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 18 Oct 2023 Medical Assistant called to inquire, what to look for? How to proceed? Medical assistant  reported they inadvertently administered Kinrix to sibling patients. MA mentioned both patients needed both DTAP and IPV and Kinrix had both but noticed the recommended age after. The HCP stated, it was the 3rd dose of DTAP and 3rd dose of IPV for each patient. The reporter did not consent to follow-up. 2 year patient received kinrix, as 3rd dose of DTAP and 3rd dose of IPV which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. This case has been linked with case reported by same reporter.; Sender's Comments:  US-GSK-US2023144288:Same reporter,2nd patient
I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died, even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Reported Cause(s) of Death: died from your vaccination
Patient states that he had vaccine on 1/13/21. He presented to the clinic 4 days later on 1/17/21 with light headedness, nausea and elevated BP 160/88 and upon recheck 175/100.  There is H/O HTN but on medication he has not been this elevated in years.
after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 17th January 2023) for prophylaxis.   On 27th July 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SLEEPY; PAIN AT INJECTION SITE; This spontaneous report received from a pharmacist concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: unknown) dose, start therapy date were not reported, 1 total administrated to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient received the covid-19 vaccine around 2 months ago. At the same day of vaccination, she felt sleepy and slept for about 1 to 2 hours. One week after the vaccination she also had pain at injection site. On 06-MAY-2021, she did an COVID-19 antibody test and the result came negative (coded as confirmed immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, and the outcome of pain at injection site and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179322. The suspected product quality complaint has been confirmed to be non-voided (The reported allegation could not be confirmed. A manufacturing related root cause could not be identified). based on the PQC evaluation/investigation performed. This case, from the same reporter was linked to 20210519950.; Sender's Comments: V0:20210519895-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient stated with red, warm rash at injection site today August 7. Woke up this am with rash, not worsening. No rash last night at bedtime. Tender, not itchy. Rash around, 2" x 1" right outer thigh.  Will treat with ice and BENADRYL.
Patient experienced fever 103 degrees,  body and muscle aches, chills, ringing in the ears, headache, loss of appetite.  Dr. suggested Tylenol and fluids for treatment. Spent 24 hours in bed as I had no energy.
Patient presented to the Emergency Department with fever and confusion. After receiving his second dose of Pfizer Covid vaccine, someone stopped in to check on him and he was confused. He had only had a donut since he got the vaccine 24 hrs ago. He was struggling to do his normal activities of daily living. Oxygen readings were in the 80s at home, heart rate was over 100, and temperature was over 100. The patient was complaining of diffuse body aches. He did not have a headache, chest pain, shortness of breath, abdominal pain, vomiting, or diarrhea. Past medical history is remarkable for chronic pulmonary disease due to asbestos exposure, Covid infection the last November. While in the ED, he was treated with a liter of normal saline, a liter of lactated ringers, 1000 mg of acetaminophen, and 600 mg of ibuprofen. His heart rate decreased and fever was gone after receiving fluids, acetaminophen, and ibuprofen.  The patient was then discharged home.
15mins p/inject c/o nausea, BP 170/130 & 140//100 later was pale; sent to ER;
No . Adverse event Pt. got a 3rd shot of Covid in error - want a shingle vaccine
Swelling in the face, jaw and lymph nodes; Swelling in the face, jaw and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Nurse)..  A 76-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, In Feb2021 with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) at dose 1 and dose 2 for COVID-19 immunisation), administration date: Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Swelling in the face, jaw and lymph nodes", "Swelling in the face, jaw and lymph nodes". The following information was reported: SWELLING FACE (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "Swelling in the face, jaw and lymph nodes".  Additional information: On 17Nov2022, it was reported that a patient started treatment on an unspecified date in Feb2021 with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) at dose 1 and dose 2 for COVID-19 immunization. It was reported that the patient had swelling in the face, jaw and lymph nodes. No further follow-up is anticipated means that company will not perform any follow-up for this report as it is a non-company product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200116707 same patient/event, different dose;
This initial spontaneous case, was received on 18-Oct-2017 from other non-health professional, concerning a 69-year-old, elderly, female patient. The patient's medical history included breast cancer and MI (myocardial infarction) since 1990. The patient's current condition included high blood pressure, that has been well controlled for years as status post MI in 1990. The patient's concomitant medications included potassium, PLAVIX, hydrochlorothiazide, pantoprazole, losartan, levothyroxine, atorvastatin, Baby aspirin, AMBIEN, and Multiple vitamins. On 11-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, anatomical location: left deltoid, batch number, expiry date, route of administration: intramuscular). On 12-Oct-2017, within 24 hours of vaccination, the patient had hacking cough. The patient also had a headache, congested sinus/nose and felt tired along with rosy cheeks which lasted for 2 days. It was reported that, the patient went to GI and the patient's BP (blood pressure) was found to be 167/97. At the time of this report, the patient was recovering from the events (cough, nasal congestion and hypertension). The causality of the event cough was related. The reporter assessed the events as non-serious. Follow-up report received on 31-Oct-2017: Outcome of the events (cough, hypertension and nasal congestion) were updated from not recovered to recovering. Amended narrative accordingly.
1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 08-Apr-2022, CDC expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Reporter stated that they have reviewed historical storage records and can verify they were properly stored the entire duration of time on site. The vaccines were removed from the freezer on the day of each respective immunization. Treatment information was not provided.
VARS reviewed with patient to which she checked and verbally confirmed never having a severe reaction to a vaccine. 5 minutes of sitting post vaccination she felt flushed, then nauseous. She asked our technician for water. Pharmacist went out to check on her - she was alert but she said at one point everything was bright and she could not hear. She had moved herself to sitting on the floor. Called ambulance just to check her out. Pharmacist monitored her to make sure she was okay until ambulance arrived. We gave her ginger ale and crackers and cold rag and water. At this point patient confirmed she was nervous about vaccine prior and has passed out from giving blood before. Patient had only eaten half a sandwich by 3 PM in the day. Ambulance arrived and reviewed patient's vitals. She decided not to go with the ambulance. Called patient about 30 minutes after event to check on her, she stated she had gotten something to eat and felt much better. Total incident took place over 10 to 20 minutes. Pharmacist referred patient to her physician for follow up.