chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Engerix administered/ which had an expiration date of 24Apr2023; 4th Hep b dose administered; Pediarix 1st dose on 20Dec2021, 2nd dose on 17Mar2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old male patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.  Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.  Previously administered products included Pediarix (1st dose was received as Pediarix pre-filled syringe on 20-DEC-2021).  On 03-MAY-2023, the patient received Engerix B. On 17-MAR-2022, the patient received the 2nd dose of Pediarix. On 17-MAR-2022, not applicable after receiving Engerix B and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: Pediarix 1st dose on 20Dec2021, 2nd dose on 17Mar2022). On 03-MAY-2023, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered/ which had an expiration date of 24Apr2023) and extra dose administered (Verbatim: 4th Hep b dose administered). The outcome of the expired vaccine used, extra dose administered and drug dose administration interval too long 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: 04-MAY-2023 Nurse reported that the patient was administered a dose of Engerix-B on 03 May 2023, which had an expiration date of 24 April 2023, which had led to expired vaccine used. The patient had received the third dose of Pediarix as pre filled syringe on 06 MAY 2022. The nurse stated this dose was the patient's fourth hepatitis b dose, and that it was given because the patient's third hepatitis b dose was administered too soon which had led to extra dose administered. The patient had previously been dosed with Pediarix vaccine. At the time of reporting, the expired dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. On 17th March 2022, the patient received the 2nd dose of Pediarix, vaccine later than the recommended interval, which had led to lengthening of vaccination schedule.
Patient's daughter called on 9/6/18 to report that mother felt very sick the night of vaccine administration (9/5/2018). She reported headache, chills, fever, vomiting. Patient took dose of TYLENOL at time of fever and again at 3am when she started to feel better. Reported no redness or swelling at injection site. Spoke to patient around 12:30pm on 9/6/2018 and is feeling a little better. Pharmacist did ask patient at the time of vaccination if they had vaccine in the past and if they had any reaction to it. Patient stated they had it in the past with no reaction. However, when daughter called to report the reaction on 9/6/18 and the pharmacist asked again if they had any similar reaction in the past that is when the patient stated that they had a similar reaction but not as strong as this year. Pharmacist asked why the patient did not tell her at the time when asked but she did not think it was a concern. Pharmacist offered to call primary doctor to inform but daughter told Pharmacist that she would contact primary doctor.
pt wakened crying nursed briefly from bottle, then became letharigc w/sl jerky movements, eyes open & unfocused; appeared unresponsive x 2 min; lethargy cont'd approx 30-45min until pt fell asleep; afebrile; slept through noc w/problems;
Information has been received from a consumer referring to her currently 24-year-old daughter via the company representative. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date on the patient's 13 years old, she was vaccinated with GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient experienced "tiredness, weakness, unable to complete normal activities, eyes rolling back in her head, her teachers could not get her attention, she was in a daze" on unspecified dates following administration of this first dose. The patient visited a physician, who diagnosed patient's symptoms as "silent seizures" and prescribed unspecified medication as treatment. The patient received a second dose of a GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) vaccine on an unspecified date; it was unspecified whether the second dose was GARDASIL or GARDASIL 9. The patient experienced "migraines, headaches, vomiting, stomach pain, and hair loss" on unspecified dates following administration of this second dose. The patient visited the same doctor, who referred the patient to visit a neurologist. The patient never received a third dose of a GARDASIL vaccine. The patient sought medical attention. The outcome of all the events was not provided. The "silent seizure" was not related to GARDASIL 9. The reporter did not provide the rest of causal relationship between reported events and suspected vaccines. Upon internal review, the event "silent seizure" was considered to be medically significant.
about 30 seconds after patient received his 2 vaccines, he lost consciousness.  his head slumped toward his chest, his eyes closed.  he remained in his chair.  I applied a cold pack to his neck and about 1 minute later he began regaining consciousness.  He asked for some water, drank about 8 ounces and noticed he was sweating on his forehead.  after about 10 minutes he said he was fine and walked out of the immunization room.
cold or flu; being achy; little bit of fever; cold or flu; This is a spontaneous report from a contactable other hcp. This consumer (patient's wife) reported for a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and first dose was fine. The patient experienced cold or flu, being achy, little bit of fever on an unspecified date. The patient's wife reported that she was calling to find out if this is a normal reaction or something that she needs to be concerned with. She says she wanted to know if it was a common side effect, which she kind of looked online but can't find this side effect listed. she was wondering if her son should have the second dose or not. Caller says that the rest of us did not experience anything like this, the first dose was fine, then for the second they had the regular symptoms of like cold or flu, being achy, a little bit of fever; but he of course has to be different. She says that her son is supposed to go back on the 15th to get his second one. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Felt tired, chills, fever, headache, nausea no treatment, symptoms spontaneously subsided in about 12 hours.
Numbness after administration of vaccine.  Area around 1 and 1/2 an inch around the insertion area.  Still feeling the same.  Feel itchy on that area but the area is numb.  If I itch and peel off the skin no pain at all.
She got her vaccine, no problems, arm was not even sore.  10 days later on the 14th she was sitting waiting on her husband who had some appointments and she had an appointment with her therapist.  She was playing some games on her phone, started feeling a little off, looked up and she felt dizzy and the room started spinning (she has had panic attacks in the past, but never had dizziness).  She got up to move around and her walking was unbalanced, and remembers standing by a wall and was asked by a lady if she needed some help.  She was still feeling well, made it to a prayer room and broke down and started bawling and felt like she was having the worst panic attack ever.  Her husband came out and he had to help her walk as she felt off-balance.  Then she felt weird that day, the next day she was OK.   Her therapist told her to check with her doctor as he felt it was not a normal panic attack.  She went to her NP on 10/18/22 and she ordered blood work, and an EKG.  The EKG was fine, and the blood work was unremarkable.  She ordered some PT for vertigo.  The following day at PT she had another one of the episodes, not as bad as the first episode.  The PT did not think it was vertigo, the episode lasted too long as she watched her have the episode.  She couldn't get into see her actual doctor until 10/27/22, that's when she ordered an MRI, US of her carotid arteries and more blood work.  She had the US of the carotid arteries on 10/31/22 which was good.  Then she had an MRI on 11/4/22.  On 11/6/22 she had the worst episode ever, she was face-timing her girlfriend and the room started spinning so fast like an amusement ride.  She called for her husband and held onto the kitchen cabinets so that she would not fall.  He took her to the ER, did a CAT scan that showed a tiny bit of calcification that they said was normal for her age.  On 11/7/22 her doctor called her and said that she had a 7 mm aneurysm and that it is a fusiform aneurysm of mid left intracranial vertebral artery.  They have set her up with a interventional radiologist in the city.  On the 8th she would need to do another CAT can with contract.  Where the MRI said that the aneurysm was 7 mm, it said it was 5 mm.  She saw her doctor that said that the CAT Scan with contrast was more accurate.  She has an APT with the interventional radiologist on Wednesday.  She also has a referral.
No Adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    Concomitant medications details were not reported by the reporter.  It was reported that patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine.  Treatment details were not reported by the reporter.
prickly sensation all over body; hot flash; kind of hot near injection site; red at injection site; itches near injection site; swollen arm below injection site; painful to touch at injection site; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (prickly sensation all over body), HOT FLUSH (hot flash), INJECTION SITE WARMTH (kind of hot near injection site), INJECTION SITE ERYTHEMA (red at injection site) and INJECTION SITE PRURITUS (itches near injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL and LOSARTAN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PARAESTHESIA (prickly sensation all over body), HOT FLUSH (hot flash), INJECTION SITE WARMTH (kind of hot near injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE PRURITUS (itches near injection site), INJECTION SITE SWELLING (swollen arm below injection site), INJECTION SITE PAIN (painful to touch at injection site) and ARTHRALGIA (joint pain). At the time of the report, PARAESTHESIA (prickly sensation all over body), HOT FLUSH (hot flash), INJECTION SITE WARMTH (kind of hot near injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE PRURITUS (itches near injection site), INJECTION SITE SWELLING (swollen arm below injection site), INJECTION SITE PAIN (painful to touch at injection site) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Client was given MMRV that was not recommended for age. Client has had MMR not Varicella. Clients current schedule was put into system. The current record was reviewed with Coordinating nurse and a plan to administer agreed on. To administer these vaccines as a catch-up schedule. The vaccine was reviewed with co-nurse and confirmed. The MMRV was administered and system would not allow it to be logged as administered. The coordinating nurse was advised, and we both reviewed the protocol again. We reviewed the recommended vaccine schedule again. It recommended that the vaccines be separate doses. The client's mother and client were informed of schedule and vaccines administered were incorrect Client and mother stated understanding and continued to agree with separate administration of the MMR and Varicella vaccines required. Event reported to Coordinating nurse and co-nurse.
IN AUGUST OF 2000, I HAD BLOOD WORK AND ROUTINE PHYSICAL. NO ANOMALIES NOTED. I HAD MY COVID VACCINE SHOTS ON JANUARY 13, AND FEBRUARY 10, 2021. I HAD BLOOD WORK AND ROUTINE PHYSICAL AT IN FEBRUARY 2021.  NO ANOMALIES NOTED. ON AUGUST 2, 2021 I WAS IN THE ER, AND ADMITTED FOR TESTING WITH ATRIAL FIB. I WAS TOLD BY DOCTORS THAT THE COVID VACCINE PROBABLY DID NOT CAUSE THE A-FIB. ON SEPTEMBER 15, 2021 THE CDC REPORTED 1491 INCIDENTS OF MYOCARDITIS (A-FIB) I FIRMLY BELIEVE THAT THE COVID VACCINE, AT A MINIMUM, CONTRIBUTED TO MY A-FIB ILLNESS. I WANT THIS INFORMATION PUT INTO MY MEDICAL FILE.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, VITAMIN D3, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), AMLODIPINE and OMEPRAZOLE for an unknown indication.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
This is a spontaneous report obtained from a contactable nurse. A 6 months old, male patient received the third dose of PREVNAR 13 on 08Apr2013 (he received the first dose on 05Dec2012 and the second on 06Feb2013) single dose, as routine immunization. Relevant medical history was unknown. Relevant concomitant medication was none. The patient developed a rash at the bottom on 11Apr2013. Relevant laboratory data was none. Therapeutic measures taken in response to the event were LOTRIMIN. The patient recovered from the adverse event. The nurse also reported that on 08Apr2013 the patient was administered a third dose of DTaP and PEDIARIX. Follow-up (22-AUG-2013) Follow-up attempts completed. No further information expected.
A physician reported that an 11 month old male received his 2nd dose of Prevnar on 9/22/00 and 24 hours, post vax, he developed diffuse redness on his left thigh, excoriated lesions on his hands and a generalized maculopapular rash. He was seen in the ER and prescribed hydroxyzine.
just getting over the flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who was just getting over the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of just getting over the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (just getting over the flu).  At time of reporting, the outcome was Unknown for the event just getting over the flu.
No adverse event until 12-23-17 while driving out of town shoulders and front of sides became painful - some relief when moving arms done, then pain would come back. Pain started after driving about 10 hours, then went away. 12-28-17 pain from elbow to wrist both sides - continued.
fever, chills, headache, shortness of breath, tachycardia, dizziness, nausea,
Flu-like symptoms; Fever; Dizziness; Chills; Sweating; Full body aches; Exhaustion; headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6201) via an unspecified route of administration on 12Feb2021 18:45(age at vaccination 31-years-old) as dose 1, single for covid-19 immunisation. Medical history included live birth patient it was reported gave birth to her first child on 12Mar2020. Concomitant medication(s) included ascorbic acid, beta-carotene, calcium sulphate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopherol acetate, zinc oxide (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not diagnose with covid-19 prior to the vaccination. The patient did not test for covid-19 post vaccination. On 13Feb2021 10:00(15 hrs 15 min from vaccination), she was breastfeeding mom and had an adverse reaction to both the first and second dose of the Pfizer vaccine. With the first dose, she started to have flu-like symptoms about 16 hours after her shot. This included a fever (101.5), dizziness, chills with sweating, full body aches, exhaustion and a headache. This lasted approximately 24 hours for the first shot. For her second shot, she had the same symptoms and experienced extreme fatigue, a fever of at least 102.3, chills with sweating, full body aches, dizziness and a headache. she started having symptoms approximately 13 hours after she shot and stayed in bed for approximately 48 hours once my symptoms started. She breastfed before, during and after both reactions. When she was unable to breastfeed, she pumped and have frozen milk from before, during and after her second dose. The milk from 3/6 and 3/7, which was when her reaction was strongest, has a green tint to it compared to her milk on a typical day. The patient received second dose BNT162b2, Lot Number: EN6205) via an unspecified route of administration on 04Mar2021 16:45. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 101.5 on Feb2021. The outcome of the events was recovered on 14Feb2021.   No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021355753 same reporter/drug, different patient and event.
Fully vaccinated and boosted once.   Full term vaginal delivery baby  baby provider  MD  Family Medicine
Patient felt queasy and his blood pressure rose. Patient remained still in his chair for the full 15 minutes - paramedics came to check his vitals and after about 15 minutes he felt better.
Pfizer vaccine was not diluted before withdrawing the 0.2 ml dose for administration.  No known harm at this time.
Pt had what felt like swelling of her tongue, some throat itching and coughing.
Chills; Headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). In January 2021, CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. Treatment information included ibuprofen was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor; Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor; Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious), GAIT DISTURBANCE (non-serious), FALL (non-serious), outcome "unknown" and all described as "Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor".  Additional information included: The patient took it and then after midnight she fell in the floor and could not get up for 7-8 hours. It happened three times after the vaccines. The patient wanted to know if that was from the vaccine or if that had been reported by other people No follow-up attempts are possible. No further information is expected.