chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing in his left ear started sounding muffled; I was given the shot and instantly, within 30 seconds felt a slight numbing feeling radiating up my arm, then to my neck and up the left side of my face.My tongue felt a little numb but not swollen; had that "metal" taste in my mouth, but that did not return; This is a spontaneous report from a contactable other HCP. A 58-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL1284), intramuscularly in the left arm on 23Dec2020 at 07:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing and latex allergy from an unknown date and unknown if ongoing. There were no other vaccines received within 4 weeks of the BNT162B2 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), fish oil (FISH OIL), naproxen sodium (ALEVE) and bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). On 23Dec2020 at 07:00 (within 30 seconds of the vaccination as reported), the patient felt a slight numbing feeling radiating up his arm, then to his neck and up the left side of his face. Then, within 15 minutes, his hearing in his left ear started sounding muffled. His tongue felt a little numb but not swollen. It was reported when he first started feeling the numbing feeling, for about a split second, he had a metal taste in his mouth, but that did not return. It took about 1.5 hours for the numbness to go away. No therapeutic measures were taken as a result of the events. Clinical outcome of the numbness was resolved on 23Dec2020 at 08:30. Clinical outcome of the metal taste in his mouth and hearing in his left ear sounded muffled was unknown. It was also reported that since the vaccination, the patient tested negative for COVID-19 on 23Dec2020.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown demographics. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unspecified dates, in 2016, reported as "starting on or after 15-FEB-2016", the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ (lot # L027719 and expiration date 28-APR-2017) oral. The temperature excursion details were reported as "Temperature: 49.9F, time fram; 8 hours, 40 minutes; there was no previous temperature excursion and it was not because the data logger". There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
Patient received in error the Flublok by manufacturer Sanofi Pasteur. Physician spoke with patient mother on date of injection in the evening: at this time mother reported no issues. Physician provided mother with her personal cell to call if any questions or issues arise. Office spoke with mother the next day as a check in. Patient mother at this time reported patient seemed more tired that usual. No other adverse effects noted.
No adverse event; He ended up using the dark pink cap as the primary series; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series) and NO ADVERSE EVENT (No adverse event) in a 7-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 21-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series).    No concomitant information was reported. No treatment information was provided.
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered a dose of GARDASIL on 01-APR-2013 (lot # H011350, Expiration Date: 21-FEB-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
Patient presented to ED after waking up dizzy with nausea/vomiting. Mild neck pain. CTA neck showed some stenosis <50% of left internal carotid artery. Patient currently admitted.
01/06/22 presents to EC ED for "recently diagnosed Covid" "worsening symptoms" "cough and increased work of breathing". PMHx of "morbid obesity, asthma, DM type II, PCOS"
This spontaneous report was received from a nurse and refers to a 12 year old male patient. It was reported that the patient does not have any pertinent medical history, drug reaction or allergies and does not use any concomitant medication. On an unknown date in December 2018 (reported as one week or two weeks ago), the patient was administered with GARDASIL 9 for prophylaxis (reported as vaccination) (dose, dose number, route, lot#, expiry date unspecified). On the same day, after vaccination the patient waited in office for observation for 15 minutes and no adverse reaction occurred. However, on the way to home the patient experienced syncope and passed out (loss of consciousness) in the car. No treatment was provided for the events. The outcome of syncope and loss of consciousness was reported as recovered (also reported as fine now). Causality assessment was not provided by the reporter. Upon internal review, syncope and loss of consciousness were determined to be medically significant.
Patient was seen in ER and transferred to medical center. Reported event that began as head extending back with stiffening, followed by shaking of arms and legs and associated with color change, and report of some secretions in mouth at end of event; event followed by a limp infant with transient decreased responsiveness. Infant was well appearing by time of transfer to our facility and remained well during period of observation.
Little white head at injection site, red, sore, swollen, hot to the touch, painful to move arm.
Extremely sore arm, wrist, hand within an hour of vaccine. 24 hours later - headache, foggy feeling, body aches, back pain, chills, nausea, joint pain.   Took 1000mg Tylenol around 1pm and felt better although nausea persisted.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 0.5 mL, lot # J004332, expiration date: 26-SEP-2014, subcutaneous. No adverse effects were reported. Additional information has been requested.
slightly swollen and itchy; slightly swollen and itchy; redness at the injection site of the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slightly swollen and itchy), SWELLING (slightly swollen and itchy) and INJECTION SITE ERYTHEMA (redness at the injection site of the size of a golf ball) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and CITALOPRAM for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (slightly swollen and itchy), SWELLING (slightly swollen and itchy) and INJECTION SITE ERYTHEMA (redness at the injection site of the size of a golf ball). At the time of the report, PRURITUS (slightly swollen and itchy), SWELLING (slightly swollen and itchy) and INJECTION SITE ERYTHEMA (redness at the injection site of the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Member has a fine, faint, red scattered rash on both arms and faint patch on both legs. Member states rash included slightly larger "bumps" size of pencil lead on Monday. Member sate rash itches and tender.
Patient presented on 4/27 for second vaccination. When asked about reactions to the first she stated she had lip swelling and blisters form the day after her first vaccination. She presented with photos in her phone of her reaction to the vaccination. On the photos her top lip was swollen and she had blisters formed. Patient did not report this reaction prior to 4/27/2021.
pt had the antibody infusion so had to wait 90 days before getting vaccinated.  pt says his arm was sore at the injection site the night after taking the vax.   Next morning he had  headache, fatigue, chills no fever, body aches, joint pain, and was nauseated.   These symptoms lasted a couple of day.
Sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 11:00 (Lot number: EP6955) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 18:00, outcome "recovering", described as "Sore left arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sore throat, shivering, fever (next morning on 11/23/09 at 6:30 AM), headache.
Breakthrough COVID case; Breakthrough COVID case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3297) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Prev Dose Product: Covid-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EL3247, Prev dose lot unknown: False, Prev dose administration date: 22Jan2021, Dose Number: 1), administration date: 22Jan2021, when the patient was 25 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "recovered" (Jan2022) and all described as "Breakthrough COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No other vaccine in four weeks. No covid prior vaccination. No known allergies reported.  No follow-up attempts are possible. No further information is expected.
Pain on left arm below deltoid. Pain has been there since vaccine was administered. Patient cannot do her exercise class.
Marked increase in seizure activity. I seizure on 1/2/21, then a cluster of about 20 e\seizures on 1/3/21, followed by 3 seizures on 1/5 and 2 on 1/6. He was seizure free for approximately 10 months prior to vaccination.. Treated on 1/3 with Nayzilam nasal spray X2 to stop seizures per doctor's order.
Got 3rd pfizer vaccine 9 months after 2nd shot. It was in my left arm. My muscle was hard, sore and a bruise at injection site. The lymph node in my left armpit was swollen and sore. My entire back really ached and was a 6/10 pain.
Dr.  stated rarely a high fever occurs that is only side effect. When I arrived for her visit I brought Motrin and asked the nurse the dosage to give, she stated Motrin not recommended, use Tylenol and the nurse would give some in the room.  The nurse stated she didn't have any and she wouldn't need anything. After he gave her the shots, two in each thigh, one bled more and she was screaming. She stopped in the car and when we arrived home she fell right to sleep and slept for hours. She woke up screaming uncontrollably, face beat red, sweating, choking she was crying so hard. Nor myself or my husband could not stop her.  Her legs were in pain. I could not even touch her gently or change her diaper. I paged the doctor and he did not call back. We proceeded to take her to the ER and she fell asleep in the car. Worrying about the flu we chose not to wait there w/the sick because they had no room for her we went home. Paged MD again Covering MD stated not to wake her, not normal to be in that much pain hours later. If she wakes up screaming give .06 Tylenol and wait 20 minutes. If crying does not stop go back to ER. She was sleeping and at 11:00 she still was not breathing right in her sleep.  I tryed to wake her and she was not responding. It took us some time to get her to respond.  She stretched alittle and continued sleeping. She went 13 hours without a bottle and I had to wake her at 7:00AM the next morning.
DVT of right popliteal, peroneal, and anterior tibial veins.  Pain behind my knee started 2/14 (day after vaccine).  Calf eventually was swollen and painful.  Saw an orthopedist 3/10 who referred for an ultrasound.  An old clot in left popliteal was discovered and a more recent one in the right leg veins.  Started on xarelto. - 15 mg bid for 3 weeks then 20 mg SID.  Saw a hematologist 4/8.  No congenital clotting factors discovered so suspect the dvt?s are secondary to Covid (left leg) and the second vaccine (right leg).  On the bloodwork done 4/8 it was discovered that I had severe iron deficient anemia (hgb of 5.1) and was referred to the emergency department for 2 units of blood.  I now have had 14 (of 16) iron infusions of ferrlecit in an attempt to bring up both iron levels and hemoglobin.  After the initial 8 iron infusions my hgb had dropped to 6.7.  Xarelto was switched to enoxaparin during hospital stay.
Patient received the Janssen vaccine on 5/7/21, he experienced flu like symptoms (fever, chills) at midnight on Friday. His symptoms went away on Sunday morning. Since then he has experienced nose bleeds multiple times a day since Sunday morning. This has been happening every day for approximately 5 minutes total per day (multiple instances). He stated that his past medical history only consists of poor circulation. Pt has already contacted his primary care physician.
Localized swelling raised macular popular area 9x7 cm over 6cm below injection site of PNEUMOVAX given 12 hours fever, chills, general malaise, general myalgia, arthralgia.
3OCT vomiting;4OCT diarrhea;5OCt ER x-rays;6OCT hosp x 2 days;dx stomach ulcer, high BP, arthritis & severe skin problem;
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first, second and third 0.5mL dose of GARDASIL on 29-JUN-2007, 29-SEP-2007 and 29-DEC-2007.  On 24-JAN-2008, the patient had a miscarriage (MSD WAES # 0902USA04384).  Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage.  Lab tests performed included unspecified pregnancy test.  This is one of two reports concerning the same patient.  Upon internal review, miscarriage was considered to be an other important medical event.  Additional information has been requested.
This spontaneous report as received from a nurse refers to a 8 months 10 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Eye burning; Feeling of particle floating in eye.; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eye burning), VITREOUS FLOATERS (Feeling of particle floating in eye.) and INJECTION SITE PAIN (Pain at injection site) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in 2017.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE IRRITATION (Eye burning), VITREOUS FLOATERS (Feeling of particle floating in eye.) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, EYE IRRITATION (Eye burning), VITREOUS FLOATERS (Feeling of particle floating in eye.) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Pt reported getting shakes, fever, chills, and aches the Friday night after receiving the vaccinations. She reports taking TYLENOL and by the next day on Saturday she was only experiencing aches and fever. Today on 8/15/17 she said her aches, shakes, fever, and chills are all gone, but she now has a rash on her left arm. She did not know when the rash started but she only noticed it since this morning.
Immunization was performed on 12/28/04 to a 2 month old baby boy. On 12/29/04, the boy began to develop a skin rash of erythematous macular papular lesions, of round shape and varied in size from 1cm to 3cm. The lesions were all over body except for th face and scalp, mostly on extremities.
Left side where shot was administered. Inner arm, left side of chest, armpit, inflamed and sore for over 3 months. Lymph nodes swollen and sore .
On 5/20/99, the pt received his 1st Lymerix injection and experienced tight, stiff and swollen fingers. On 6/11/99, he received his 2nd Lymerix injection and the symptoms worsened. The pt was treated with prednisone, Vioxx and Celebrex. The treatment has reduced the symptoms, somewhat, but they still are present. Additional information has been reequested.
I felt strange immediately and wa iui ted an extra 15 min. I was traveling went home got my things got on a plane to. By 11 that night I was in a coma, kidneys failed and had cardiac arrest. The emts brought me back but had kidney failure.
Expired Engerix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-week-old female patient who received HBV (Engerix B) (batch number 5295P, expiry date 27-DEC-2022) for prophylaxis.   On 19-APR-2023, the patient received Engerix B. On 19-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter asked about further guidance on this situation.  The reporter consented to follow up. The patient received an expired dose of Engerix B, which led to expired vaccine used.
I could not move for a day and half. I could not stand or get off the bed. This lasted for about a day and half. I been having joint pain in shoulders, hip, wrist, ankles, and knees and has been going on since Dec 30th. I went to an Ortho specialist about this. They did blood work, normal results. They are referring me to a rheumatologist. I have an appointment in June.
Weak pulse , not as strong , heart felt heavy and low O2 when I was exercising.  Could not get / catch breath.
Pt developed bells palsy, treated with steroids and is improving. Occurred approximately 24 hours post MMR vax.
Admitted to hospital on 04/07/2021 with acute Pulmonary Embolism ( no history of thrombosis in past)
Initial report received from a healthcare professional on 24 January 2013. A 39-year-old female patient, whose concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (batch number: UT4472A) in right deltoid on 23 January 2013. The patient had no illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were not enquired by reporter. On 23 January 2013 (same day of vaccine) the patient's jaw felt funny by her left ear and on 24 January 2013 patient reported facial numbness and left side of face appeared different than the right. Laboratory investigations/relevant diagnostic tests and corrective treatment were not reported. At the time of this report, the outcome of patient was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 05 April 2013. The patient's outcome was recovered on an unspecified date.
Headache over the weekend; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache over the weekend) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEADACHE (Headache over the weekend). At the time of the report, HEADACHE (Headache over the weekend) outcome was unknown. Not Provided          No concomitant medication information provided by the reporter. No treatment information provided.
Employee was fully vaccinated with Pfizer on 12/31/2020 and 01/25/2021 @ Hospital. Employee became ill on 08/05/2021 and tested PCR positive on 8/13/2021 @ a Health clinic
On evening of 06/23/08 patient ran a low grade fever of 99.  06/24/08 mom noticed decreased movement to lower extremeties.  Infant would not push with her legs.  06/25/08 Infant with decreased movement to upper and lower extremetiesand continued with low grade fever 99. Mom stated her extremeties were limp. Infant eating, responsive and able to move extremeties but mom states movement was very lethargic.  Infant was evaluated at the ER on 06/26/08 and was sent home with out any concerns or treatment.  Patient was also evaluated per Dr. on 06/30/08 for unusual reaction.  Patient was moving her extremeties with out difficulty at this visit and returned to her normal behavior.  No treatment given.
Swilling and redness at the site, fatigue x 2 days, headache, and fever.
vaccine given 6/6/22, beyond use date is 6/7/22, but expiration was 5/31/22