chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menquadfi was administered to a patient with a 0.5 inch TB needle instead of the recommended 5/8 to 1 inch length needle, with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case from a nurse.  This case involves 18 years old male patient to whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered to a patient with a 0.5 inch tb needle instead of the recommended 5/8 to 1 inch length needle, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 24-Feb-2023, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine at a dose of 0.5 ml lot W006721 via unknown route in the right deltoid for immunization.  On 24-Feb-2023, menquadfi was administered to a patient with a 0.5 inch tb needle instead of the recommended 5/8 to 1 inch length needle, with no reported adverse event (wrong technique in product usage process) same day latency following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  It was reported "Caller unsure if the injection was given subcutaneous or intramuscularly. Wanting to know next steps to take."  Action taken: Not applicable.  Outcome: Unknown.   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.
A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 24-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route of administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 vaccine had two temperature excursions; one of 192 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and the other one of 1152 hours with a lowest recorded temperature of 33 F (0.555555556). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
After receiving the vaccine and after his observation period Client was walking up to the pharmacy counter and he fell and dropped to the ground.  He never lost consciousness, EMT was called and they evaluated Client.  Client left the pharmacy with his family member who was contacted after he fell.  Client said he felt funny , dizzy and lightheaded.
Patient reported to the pharmacy (a week after receiving the vaccine) that she experienced severe bruising, bleeding and swelling of her arm after receiving this vaccine and was still swollen and brusied. She was applying ice to her arm and this was helping with the pain, swelling and bruising.
I started getting a headache about an hour along with pain in the back of my neck and a mild headache after my shot (maybe an hour or so).  Around 1100 hours, about the time I got back from the Facility, I began to feel a tightness in my throat and got a little raspy.  When I drank water and ate a little, it hurt similar a hangover as if dehydrated, but went away after a minute or so. About 1400 hours began to develop chills, causing me to get into bed, and then the chills, overall muscular pains, very tired, moderate headache and some nausea ensued as well along with an initial low grade fever.    Fever went up to 102.1 degrees and had fever till about 2130 hours and broken only after I took two (1) Tylenols. Still had a very low grade fever till about 2300 hours or so (99-100), but finally went away.    I awoke next day (13 APR) about 0800 feeling a bit better, but with a moderate headache and touch of diarrhea.  Headache lasted all day.  This prompted me to contact my treatment facility and a telecall was conducted giving them my symptoms.  They recommended Rizatriptan should my headache continue and Tylenol not enough to relieve.  I cannot take any analgesics due to my liver disease and Thrombocytopenia.  Finally  my headache went away (with a slight hint it might come back), but no more fever, chills etc.    On 14 APR, no more headache but still felt a little tired.  From 15 APR through today (16 APR), no further symptoms and feel great, but prepared to report anything that may develop laer.
Less than 24 hours after receiving first shot, my 17 year old daughter started experiencing heart palpitations.  Her resting heart rate is 63.  She has an Apple Watch and was able to track her rate.  Highest was 123, then fluctuated between high 100s and low 110s.  It lasted until Tuesday (and slowly lowered). By Wednesday morning it returned to normal.  It frightened her and kept her awake at night.
an expired diluent for ActHIB was used for vaccine administration to a patient, no AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case involves a patient (age and gender not reported) who received 0.5 mL an expired diluent for HIB (PRP/T) VACCINE [ACT-HIB] vial, (Lot Number:UJ112AA, Expiration Date : 21-Jun-2020; Lot Number:UJ112AAC, Expiration Date :21-Jun-2020) once via an unknown route at an unknown administration site for prophylactic vaccination on 23-Jul-2020. It was also reported (Local Trade Name: Act-Hib Lot Number:U6573AD,Expiration Date :2021-03-22)  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medication were not reported.  It was an actual medication error due to expired medical agent used (expired product administered). It was reported there was confusion with the expiration dates printed on the vaccines which gave room for misinterpretation thus expired component of vaccine was given.  At the time of reporting, no adverse event was reported.  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 Directive and Module VI of the 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.
Entire right arm swollen and warm to 7.5" in diameter vs 6" opposite arm.
After 2nd shot - patient slumped to side, eyes rolled back - and after laying her back on table had seizure-like spasm < 5 sec. Called doctor - patient was laughing and left shortly after that. Checked vitals and was ok.
Itching all over the body; Red circle in the injection site that goes almost from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) and VACCINATION SITE ERYTHEMA (Red circle in the injection site that goes almost from the shoulder to the elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Reaction to previous exposure to any vaccine (shingle shot).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (Itching all over the body) and VACCINATION SITE ERYTHEMA (Red circle in the injection site that goes almost from the shoulder to the elbow). At the time of the report, PRURITUS (Itching all over the body) and VACCINATION SITE ERYTHEMA (Red circle in the injection site that goes almost from the shoulder to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Fever for 3 days over 100 F. Treatment: OTC acetaminophen Muscle pains. Treatment: OTC acetaminophen Lymph nodes pains and swelling Low oxygen saturation (89) Severe fatigue Couldn?t walk unassisted Rectal and vaginal bleeding 3 days after injection
Pt developed redness, swelling, pain, and warmth around the vaccine site. She was treated with keflex.
2 days after vaccine admonistration, patient return with complaints of swelling, and pain on one of the sites where vaccines were given. She had no fevers.
Pt returned next day with localized redness, swelling, stiff, hot injection site. Pt does not complain of other allergic sx or fever not involvement with tongue or ability to swallow.
My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call from the nursing facility that my Mother was having uncontrollable seizures and had to be transported to the nearby hospital. The ER doctor confirmed that my Mother had tested positive to Covid. She was treated for Covid and was on life support. A few days later we received a call that my Mother had a  major stroke. She passed away on January 4, 2021
have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; numbness at times in her right foot; This is a spontaneous report from a contactable nurse reporting for herself. A 33-years-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EK9231, via an unspecified route of administration on 28Dec2020 16:45 (33 years old) as a SINGLE DOSE for COVID-19 immunization.  Medical history included High blood pressure from an unknown date and unknown if ongoing.  Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included sertraline, melatonin, colecalciferol (VITAMIN D), folic acid, iron (PRENATAL).  The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021, the patient experienced have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine. Patient also had some numbness at times in her right foot on 07Jan2021. She has not been able to see her primary care provider but has an appointment in Feb to be evaluated.  The events were non-serious. No treatment was received for the events. Outcome of the events was not recovered. The patient received the second dose on 19Jan2021 in the Left arm lot EL3302.
Approx. 12 hours after 2nd dose started experiencing chills then  sweating.  Fever ~102F; Fatigue; headache; minor body aches; chills; sweating; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received second dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 AM as DOSE 2, SINGLE for covid-19 immunisation (at the age of 39 years). The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 10 Feb2021 10:00 AM (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. On 01Mar2021 22:30 patient experienced approx. 12 hours after 2nd dose started experiencing chills then sweating. Fever 102F. Fatigue, headache, minor body aches. Fever lasted 36 hours. The patient was not received treatment medications. 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 event was recovered.  No follow-up attempts are possible. No further information is expected.
got two doses of vaccine and I have them again/ Suspected vaccination failure; Shingles; hurt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in November 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the suspected vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and had shingles again now  The patient stated that the shingles hurt so bad. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was not provided.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history regarding the multiple unspecified patients was not provided. On multiple unspecified dates the multiple unspecified patients might be vaccinated with improperly stored doses of VARIVAX (lot # L044525, expiration date 07-NOV-2017, dose and route unknown) for prophylaxis. The vaccines were exposed to 18.3 F for 1 hour and 10 minutes. The temperatures were logged with a data logger and there were no previous excursions. No adverse effects were reported. Additional information has been requested.
A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 05-Oct-2013. It was reported that nurse had inadvertently given FLUMIST to a 15 months old child which started on 05-Oct-2013. The patient recovered from the event of inadvertently gave FLUMIST to a 15 month old child on an unspecified date. The report was considered to be non-serious.
DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDED HERE) NUMB LIPS AND TONGUE THROAT HOARSE LEFT ARM ACHE
redness, warmth, and swelling to Right arm at injections site. Tender to touch and with movement
Body aches, head ache, fatigue -- lasted several days, and kept me from my normal activities. After a few days, I was back to usual activities except for exercising. But I haven't felt well the vaccine then and it has been over 1 week. I don't have the same energy level as before and my stomach is slightly upset. I am thirstier than usual.
About 5 mins after patient received first dose of her pfizer vaccine, her mother got my attention that she was not feeling well. I went outside and saw that her eyes were starting to roll back into her head and ended up passing out. With the help of the patients brother i helped her from the chair she was sitting on to laying flat on the ground. After about 15 or so seconds patient came to and was responsive. She was able to tell me her name and where she was at the time. I had dialed paramedics just  to be safe. I helped her back into her chair so she could recover until the paramedics arrived. Once they arrived and took over, the patient elected to leave the pharmacy under her own power with her mother instead of making a trip to the hospital.
7 days after 1st shot I developed several pimples within an inch of the vaccination site. One had a big white pus head, the other was a larger round shape puffy clear plus looking one, add several smaller tiny pimple rash. Within 2 days they almost completed disappeared.  But I still went to see a doctor who examined me and said most certainly a reaction to the vaccine as I have had no intimate contact with anyone for close to 3 years, no attendance at large gatherings, no massages, nothing involving close contact. Today now 7 days after appearance there is a very small scar where one used to be, and nothing for the others
Fever; body aches; headache; lethargy; large lemon-size lump under right armpit. Very painful.
Within 8 hours of vaccine:  vomiting, fever of 104.5+ Seizure   Lethargic   Hospital visit to bring down fever, was instructed to continue on Tylenol and Motrin to help bring down fever, encouraged to push fluids.  Upon calling doctors office, it was suggested that he picked up a "bug" NOT POSSIBLE
Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part and received both/  no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number-00573548) and transmitted to Sanofi on  22-Apr-2021.  This case is linked to case 2021SA138518 (same reporter).  This case involves a 2 months old male patient who was vaccinated with a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6986AA and expiry date 22-Jul-2022) once on 21-Apr-2021 and POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] via unknown route in unknown administration site for prophylactic vaccination on an unknown date, Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part, what issues might two doses of IPV cause (Extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) for prophylactic vaccination.  This was an actual medication error case due to extra dose administered (latency was same day).   At the time of reporting, no adverse event reported.  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 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.
flush feeling; I had to think about swallowing before swallowing; scratchy swollen throat; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date (at age of 50-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced flush feeling, I had to think about swallowing before swallowing and scratchy swollen throat. The caller stated that the patient had a flush feeling and feeling that the patient had to think about swallowing before swallowing, but those feelings felt better 25 minutes after. The patient didn't need help and the patient drove himself home. The caller stated that were the symptoms going to be worse when he took his second dose. The patient worried about having an allergic reaction. Caller received first dose of bnt162b2 vaccine and had mild reactions to it. He experienced scratchy swollen throat and flushing. He was wondering if the side effects were the same for the first and second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  Acute COVID-19 infection. Hospitalized after completion of Pfizer vaccine series.
We had a Influenza Shotex event and had a 7 year old patient receive only half the 0.5ml flu vaccine due to the child flinching/pulling away that the needle came out and the person providing the vaccine accidently locked the needle with the safety mechanism.
07/03/2003: 24 mm. Induration on 35 mm. erythematous base right deltoid.  Prescribed with warm, moist heat and 1mg claritin/d.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt some lightheadness and felt she was having a panic attack. sje slumped but patient was responsive