chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough Infection- Positive antigen test 03Jan2021; Breakthrough Infection- Positive antigen test 03Jan2021; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Dec2021 14:00 (Lot number: FE3594) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administered in arm right, administration date 29Apr2021 13:00 (Lot number: 003C21A) as dose 2, single and intramuscular, administered in arm right, administration date 02Apr2021 14:00 (Lot number: 031B12A) 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: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Dec2021 14:00, outcome "unknown" and all described as "Received dose 3 as BNT162B2 but initially received 2 MODERNA COVID-19 VACCINE"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" and all described as "Breakthrough Infection- Positive antigen test 03Jan2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Nasal Swab; (03Jan2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: The patient was not diagnosed with covid-19 prior to vaccination. The patient did not have other vaccines in the last four weeks. The patient has no known allergies.
injected in the subcutaneous tissue instead of the muscle; site felt itchy that night and there was a big hole a quarter of a penne size/it blistered with an open hole in the arm and was itching; site felt itchy that night and there was a big hole a quarter of a penne size/it blistered with an open hole in the arm and was itching; This is a spontaneous report from a contactable other hcp (nurse (patient itself)) Pfizer-sponsored program. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, Expiry date: unknown), dose 1 subcutaneous route, administered in Arm on 05Feb2021 (at the age of 47-years) as dose 1, single for covid-19 immunisation. Medical history included asthma (treated with asthma inhaler) and diabetes. Concomitant medications included insulin for diabetes, "water pill" and "asthma inhaler". It was reported that patient got her first dose of the COVID-19 vaccine last Friday on 05Feb2021. Patient said she was injected in the subcutaneous tissue instead of the muscle. She reported that site felt itchy that night and there was a big hole a quarter of a penne size. She stated she showed her doctor and it blistered with an open hole in the arm and was itching. She stated she took the band-aid off and it was itching profusely and it was macerated and looked like a blister had busted. It was like a quarter size of a penny, 1/4 size of a penny, and the hole was deep about 2-3 cm below the top layer of skin. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Tingling at the injection site; Red,raised, warm spot on my arm ,at where i got the shot; A spontaneous report was received from a consumer , concerning  30 years old female patient , who received Moderna COVID-19 vaccine(mRNA-1273)  and experienced events vaccination site erythema and vaccination site paraesthesia .  The patient's medical history was not provided .Concomitant medications were also not reported .   On 30 Dec 2020 , prior to the onset of events , the patient received their first of two planned doses  of mRNA-1273(Lot/batch: unknown) through intramuscular route of administration  for  prophylaxis of COVID-19 infection.   On 06 Jan 2021 ,  patient experienced events red, raised, warm spot on arm at the injection site. It was oblong, 3-4 inches in diameter and had a slight tingle and on 07 Jan 2021 , it got bigger .  Action taken with mRNA-1273 in response to the event was not reported .  At the time of this report ,outcome of the events vaccination site erythema and vaccination site paraesthesia was unknown.; Reporter'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.
The patient stated in his electronic form that he faints with shots. I questioned him about it, and he acknowledged, stating that after going through chemotherapy and having multiple blood draws and shots, that it has seemed to have gotten better over the last several years. He gave the phone numbers of his grandfather and girlfriend in case they were needed. During our brief discussion, the shot was administered as the patient was talking me. He stated that having the discussion to distract him was helpful. I stayed with the patient because of knowing his history. Approximately 2 minutes later, he said he did not feel well and he passed out, sitting upright in the chair. If not for the CPR training, I think the situation could have been a lot worse. The patient was unresponsive and displayed agonal breathing. After removing his mask and unable to find a pulse (brachial or radial), I laid him on the floor, opened the door from the clinical services room, instructed call emergency then a code white. Shortly thereafter, as I was preparing to start rescue breathing and CPR, he came around and medical worker arrived promptly, along with the officer. Medical worker contacted his next of kin and EMS arrived shortly thereafter.
Apnea. Neck stiffness. Red face. From initial information received on 04/Dec/2003 from a physician regarding an adverse event occurring in the USA, it was reported that a two month old male patient received a dose of IPOL (lot number, route and site of administration not reported) a dose of DAPTACEL (lot number, route and site of administration not reported), a dose of COMVAX, manufacturer Merck (lot number, route and site of administration not reported), and a dose of PREVNAR, manufacturer Wyeth (lot number, route and site of administration not reported), on 23/Sep/2003 at 1:00 PM. Approximately five hours later, at 6:25 PM, the patient was found lying prone with a hyperextended neck. His face was red and he did not breathe for five seconds, but was then fine. He was seen in the office by the physician the next day and was fine. Reportedly, the patient recovered from these events.
THE PATIENT GOT 2 DOSES OF MODERNA BEFORE, SHE CAME TO GET THE BOOSTER SHOT, SHE MISTAKENLEY RECIEVED THE PFIZER SHOT INSTEAD.
Vaccine administered at 12:15 PM; onset of headache around 7:15 PM; onset of severe fatigue about 1 hour later.  Headache lasted all night; fatigue lasted through the following day.
ACUTE NON ST ELEVATION MI CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE AND CHRONIC POSTTRAUMATIC RESPIRATORY FAILURE, UNSPECIFIED TYPE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
Left arm began hurting. Within 2 days it moved up to my shoulder. Within a week I began to realize it was hard to hold my head up. I still have trouble holding my head up. My head feels like it is very heavy. This is putting more strain on my shoulders.
The barrel of the syringe popped up / It separated from the needle; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; The medication hit the patient and as a result some of the vaccine got into his eye; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), described as "The barrel of the syringe popped up / It separated from the needle"; PRODUCT ADMINISTRATION ERROR (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), EXPOSURE VIA EYE CONTACT (non-serious), UNDERDOSE (non-serious) and all described as "The medication hit the patient and as a result some of the vaccine got into his eye". Additional information: Caller stated they had been injecting the new Comirnaty 2023, 2024 vaccine and then the barrel of the syringe popped up as he was injecting the vaccine to a patient. Caller added it separated from the needle and the medication hit the patient and as a result some of the vaccine got into his eye. Caller wanted to know what to do about it, if he should flush the patient's eye. Caller said he's not concerned about reporting any product quality issue regarding the product but he just wanted to seek guidelines. Eye contact: Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician. Skin contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention.  Causality for "the barrel of the syringe popped up / it separated from the needle" and "the medication hit the patient and as a result some of the vaccine got into his eye" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previous information: Suspect drug was updated from BNT162B2, BNT162B2 OMI BA.4-5 to Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).  Amendment: This follow up report is being submitted to amend previously reported information: Suspect drug was updated from Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) to BNT162B2 OMI XBB.1.5. Device issue was added as event.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Health Authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA277871, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, 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 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.
Within 6 hours of vaccine, I experienced marked fluid retention and difficulty urinating. Within 14 hours of vaccine, fluid retention became visually evident - hands, ankles, legs, feet and abdomen. Also extreme aches in joints especially hands and shoulders.
Numbness of lips and nose, upper back pain, light headedness, fatigue, soreness at injection site, and headache.
My father received Moderna vaccine and next day morning he is got high temperature and body ache. He himself is doctor presently practicing
Severe pain on left side- unable to move left side arm, shoulder, neck. Unable to sit up on own, unable to complete daily tasks on own without major support from another person. Unbearable pain.  9:00pm on 3/31 to present (pain medication has made pain more manageable)
1/24/2020: Dr. appointment with Dr., HPI: Rash on upper legs over past day, itchy.  Otherwise well.  Parents wonder if it was from vaccinations 1/16, received MMR and DTAP IPV.  Otherwise well.  No fever or chills.   No cold symptoms Plan:  Rash.   Parents were reassured.  Possibly due to recent vaccinations , or viral.  Claritin 5 mg in am & Benadryl 12.5-25 mg in pm, Cortaid / hydrocortisone cream to itchy area as needed.  Return to clinic if no improvement or any worsening of symptoms over the next 48-72 hours.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 07-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a sales representative via another sales representative and described the occurrence of influenza A virus test positive in a child (age 6 - 10 years) male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (release date 20 July 2011). Less than one year after vaccination with FLUARIX, the subject contracted influenza A virus. The subject tested influenza A virus test positive and experienced vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. No additional information was reported. This case in linked to two additional reports received by the same reporter involving vaccination failure following FLUARIX vaccination. Linked cases include: A0980249A and A0980250A.
loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered.  Information on the lot/batch number has been requested.
PATIENT PRESENTED WITH SWOLLEN, RED,  INFLAMED CIRLCE NEAR POINT OF VACCINATION.  POINT HAD FEVER AT TIME OF REPORT 10/13/2023 AT 945AM.  PATIENT SAID INFLAMATION AND SWELLING HAD DECREASED OVER PREVIOUS 24 HOURS.  PATIENT'S PRIMARY DOCTOR'S OFFICE WAS NOTIFIED.  PATIENT SCHEDULED FOR OFFICE CHECK AT 10:15AM 10/13/2023
1/5 vaccination 1/9  I took a shower and noticed a lot of red dots on lower abdomen. Was very odd.  1/10  Increased amount of pin sized dots. I went to urgent care.  Upper thighs to chest; hundreds of them.  Cherry Angioma.  The spreading has decreased to a couple on the face.  Dent in arm from vaccination at injection site. Feels like 'pop rocks'.
Extreme exhaustion, brain fog, runny nose, smell burning odor, and feeling body is swollen.
Significant, localized rash at injection site of High Dose flu shot. no shortness of breath or throat tightness or any other problem.
3 days later had axial aches & pains x 10-12 days which resolved; no other signs or sx; poss adverse rxn;
Patient presented to emergency room for possible reaction 2 days after 2nd dose vaccination and was subsequently cleared and discharged.  Patient presented again on day 4 after vaccination with vomitting and chest pain.  Patient was admitted to hospital for myocarditis, possibly related to 2nd dose administration of Comirnaty COVID-19 vaccine.
Received flu shot on Fri 1030pm. She remembers seeing a rash on her hands Sunday 9/22/13 and on Monday 9/23/13 woke up with hives (rash) on bilateral arms. Denies doing anything this weekend that may have contributed to hives.
On initial reaction on 1/20/2022 I had hives on my lower and upper back and chest, neck, face, bottom of feet, ankles, and thighs. My lips were swollen and my eyes just about swelled shut. Majority of the symptoms happened at night. During the day changes of temperature or stress/anxiety triggered them. During the day mostly hives on my neck, forearms, and hips would appear. This hives are no longer to that extent but I still to this day get hives every night and randomly during the day on the bottom of my feet, hips, butt, and upper back/neck. I took 1 tablet of Pepcid and Claritin after my prednisone dose which calmed the hives temporarily. Since going off of Pepcid and Claritin the hives are back in full force.
administered multiple FLUZONE QUADRIVALENT vaccines that were expired at an employee health clinic with no adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00817224.  This case involves an unknown age and unknown gender patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Expired product administered).   The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Solution for injection   lot number and expiry date not reported via unknown route in unknown administration site prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "He states that none of the employees received any other vaccines concomitantly. He does not have individual patient information or lot number at hand, accepts follow-up contact to provide details if desired."  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 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.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml(thimerosal free, lot # L033343, expiration date 13-SEP-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 24, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same reporter. Additional information has been requested.
Patient received a different vaccine type for his second dose. Patient should've received 2nd dose Moderna, instead he received Pfizer 2nd dose vaccine