chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels like she is high, like under the influence; This is a spontaneous report received from a contactable consumer or other non hcp. A 23-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown, Expiration Date: unknown) via an unspecified route of administration in Arm Right on 24Aug2021 14:00 (age at vaccination 23years old) as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Valtrex she has been on this for a couple of months on unspecified date. On 24Aug2021 the patient experienced feels like she is high, like under the influence. Additional information provided she feels like she is high, like under the influence. She is feeling began 20-25 minutes after she had the vaccine today, 24Aug2021. She had to wait 15 minutes after the vaccine and then she sat in the parking lot for another 20 minutes to make sure she was understanding her body correctly. She had to go home, and she doesn't have anybody out where she lives so she was driving as careful as she could. She feels so high in her body. She can't stop crying because she is so high. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
The next day I felt chills and fatigue. Then I felt okay. Then felt fatigue 5 days later. I had to call in sick to work. I had swelling in left lymph nodes under armpit that lasted 3 weeks. I have fatigue and body aches that I wasn't having before that is still happening today. I went to see my doctor 12/17/2021 and she diagnosed me with Fibromyalgia, and believes the vaccine stirred it up; a flare up.
My adverse event started on 10/2022 at night. I woke to urgency to use the bathroom. I have explosive diarrhea. I took IMODIUM but it didn't help. It happens frequently especially at night when I lay down. My digestion has  completely changed. I went to my doctor's office on 12/2022. He referred me to a GI doctor who then diagnosed me as having Chron's and Pancreatic insufficiency. They wanted to prescribe me medication but since I was having other problems they wanted to rule out everything before prescribing any medication. As of now I am taking montelukast, lisinopril, probiotics, CULTURELLE, and simvastatin. I also went to a Nutritionist last week who prescribe milk thistle, berberine, illicium supreme, col golden supreme. This medication was given to help with digestion to break down the enzymes. My doctor and other specialist are trying to rule out the issue I am experience. I had 6 Colonoscopy's within the last 30 years. On 03/23/2023 I will be having a CT Scan with contrast for Abdominal and Pelvis. My problem is still ongoing and hasn't resolved yet.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 2 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 33, 0.555555556 and R; 48, 34, 1.111111111 and R. This is one of several reports received from the same source. Additional information has been requested.
A non-serious report of Influenza has been received from a pharmacist concerning a four-year old female subsequent to FLUMIST. This case is subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reported for the newly indicated population of 2 years to 59 months of age of FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received a total of one dose of FLUMIST on 23-Sep-2009. The patient experienced the event of Influenza, fever, runny nose, and positive flu test, on 25-Sep-2009. She was treated with oseltamivir phosphate. Outcome of the event is unknown. All follow-up attempts per company SOPs have been completed.  No further information is available.  19-Feb-2010.
a lot of the medication was leaked out from the sides of the needle resulting in an under dose,as an occupational/accidental exposure with no reported adverse event; Initial information (received on 19-Sep-2022 processed as non-case) with additional information 19-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist. Agency number: 01284280.  This case involves a 63-year-old and unknown gender patient who experienced a lot of the medication was leaked out from the sides of the needle resulting in an under dose, as an occupational/accidental exposure with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Sep-2022, the patient received suspect FLUZONE QIV NP at dose 0.5ml once via intramuscular route in the left deltoid (lot: UT7701MA, expiry date: 30-Aug-2022) for Influenza immunization. The patient used the product first time.    On 17-SEP-2022, the patient developed a non-serious a lot of the medication was leaked out from the sides of the needle resulting in an under dose, as an occupational/accidental exposure with no reported adverse event (accidental exposure to product) at same day latency.  Pharmacist calling to inquire about a FLUZONE QIV NP, a patient was receiving vaccination on 17Sep2022, the needle they used was damaged and a lot of the medication was leaked out from the sides of the needle resulting in an under dose. They are seeking guidance on how to handle this situation. This situation is reported as an occupational/accidental exposure.   Action taken: Not applicable. The patient was still using product.   At time of reporting, the outcome was 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.
Sharp body pains; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sharp body pains) and FATIGUE (Feeling very tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A, 021C21A and 045J21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Sharp body pains) and FATIGUE (Feeling very tired). At the time of the report, PAIN (Sharp body pains) and FATIGUE (Feeling very tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Treatment medication were reported.   This case was linked to MOD-2021-405859, MOD-2021-405861 (Patient Link).
Blood clots in left leg - superficial vein.  Judged to be caused by long-standing varicose veins.  family history of varicose veins and blood clots.  Over 2 months since booster vaccination.  Does not appear that could possibly be linked to vaccination.  Entered the adverse event in VSafe only because it did not specify to enter only events that could be caused by vaccination.
Morning after the shot was woke up with severe vertigo. It hasn't stopped since. Currently on day 22 of vertigo.  I've seen my regular doctor and we tried the Epley maneuver. I've been to a chiropractor for three visits with a little relief.  Next I'm scheduled to go to ENT doctor.  Nothing so far has stopped the vertigo.
Big red spot now 50 cent piece size R arm cant' move. Feel fine other then.
On 8/9/17, patient developed redness and swelling of left upper extremity. On exam, 7 x 11 cm area of redness with 3cm x 3cm area of induration. KEFLEX started.
Patient with swelling to left side of lip, throat, and  difficulty swallowing after receiving covid-19 vaccine . Pt had vaccine on 5/22/ 2021(Saturday) and had delayed reaction on 5/23/2021 (Sunday).  Pt treated in ED with Sodium Chloride 0.9 % IV Bolus, diphenhydrAMINE Inj 25 mg (BENADRYL), Famotidine (PF) Inj 20 mg (PEPCID, methylPREDNISolone Sod Succ (PF) Inj 125 mg (SOLU-Medrol PF).
On 9/28, 5 days after receiving rotateq,  infant presented with crying episodes, followed by fatigue and blood in his stool. Abdominal Ultrasound confirmed an ileocolic intussusception. Intussusception self reduced without medical intervention on repeat ultrasound that was done upon transfer to another institution.
sore throat; I woke up with a sore throat. I feel it in my ears to; diarrhea; fatigue; aches and pains; feels like she has the flu; strep throat; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 29Mar2021 (Batch/Lot Number: 8732) as single dose for COVID-19 immunisation.  Medical history included obese, thyroid, fibromyalgia and bell's palsy from 2016 and ongoing. The patient's concomitant medications were not reported. Patient took the first shot on 29Mar2021 and she was due today for the second shot. The caller woke up with a sore throat and it was kind of in the ears feeling on 19Apr2021. The caller almost felt like she had the flu and diarrhea really bad on 19Apr2021. The caller's throat almost feels like strep throat and she has aches and pains on 19Apr2021. Patient felt fatigue. Events onset on 19Apr2021. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
fatigue, mild headache, lump in throat, sore throat, coughing, phylum, severe runny nose, congestion, dizziness,  tired, itchy eyes, lethargy    Reporting here and called pharmacy yesterday.  Have not called PCP yet as weekend.
diarrhea  and vomiting for about 18 hours, aches and fatigue.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048456, expiration date: 25-MAY-2017; dose and route of administration were not provided). On the same day, the patient was also vaccinated with M-M-R II, VARIVAX and PREVNAR. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Noticed a raised "red" bump - HOT TO TOUCH two weeks after the shot, that was about two (2) inches in diameter.  I took Benadryl that night, and it was gone by the following evening.  As a precaution, I went back to the Urgent Care location the following morning, and they said that it was a delayed reaction.
Heart palpitations / arrhythmia. Heart skips a beat or flutters. Currently waiting to schedule an appointment with a cardiologist.
Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Headache; Eyes are sore; Soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), via an unspecified route of administration on the upper right arm, first dose at age 84 years on 15Jan2021, at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient had the COVID Vaccination on the 15Jan2021 and he had minor soreness in his arm for 2 days and it went away, it was gone by the 18Jan2021. On 23Jan2021, he started with the symptoms similar to the thrush of the mouth and he went to the doctor 27Jan2021 and they told him it was not thrush because he did not have the white coating in his mouth, and thought it was reaction to the Covid-19 Vaccination (Covid-19 Vaccine by Pfizer) and he has a sore throat and all inside his mouth is sore, his tongue is sore he has headache and his eyes are sore. Patient's doctor told him to take Vitamin C and Vitamin D and Zinc, and he took his first dose this morning 27Jan2021, after breakfast which are Vitamin C and Vitamin D, but he haven't taken the Zinc yet. The outcome of the event soreness in arm was recovered on 18Jan2021, while for the rest of the events, it was unknown.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 18 yo male fell out of chair and hit the left side of his head, ~5 min after receiving vaccine. The patient reported that he remembers becoming dizzy prior to falling out of chair. A nurse and pharmacist immediately placed him onto a sheet and elevated his feet. He was diaphoretic, warm to touch and awake. His initial blood pressure was 89/58. 2nd-4th readings were WNL. He was given water, an icepack for neck and abrasions on his face were treated. He reported that he was feeling much better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 16Dec2021 as dose 3 (booster) single (Lot number: 7J8762) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin's lymphoma", start date: Oct2013, stop date: Apr2014, notes: Hodgkin's Lymphoma - diagnosis Oct2013, complete remission as of Apr2014 - no known relapse; "Allergy" (unspecified if ongoing); "cold" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA taken for hypersensitivity, start date: 01Aug2015; NYQUIL taken for nasopharyngitis, start date: 12May2022, stop date: 13May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received treatment anti-viral Product Brand Pfizer Paxlovid, Treatment start date- 14May2022, Lot number- GA5120, Indication- Treatment of COVID-19. About 30 minutes after taking first dose, patient experienced a bitter taste in mouth/on tongue that has not gone away with eating or drinking. It tastes similar to the bitterness of BC Powder. It is not unmanageable, and she will continue taking the medication even if she continue to experience this AE.
Information has been received from a nurse concerning a 23 year old female patient who had on adverse effect her first dose of GARDASIL and on approximately 24-MAY-2010 was vaccinated with a second dose of GARDASIL (Lot # not provided), 0.5 mL. After vaccination, the patient waited 5 minutes before she stood up. When she stood up, she felt faint and sat down and then passed out. She fell down and hit her head on the floor and got a knot on her head. She laid down at the office. Every time she would feel fine she would stand up, but every time she stood up she would feel dizzy and laid down again. After two hours an ambulance was called and she was brought to an unspecified hospital. It was unknown if the patient was admitted. The patient now said she felt "fine", but the nurse did not know if the patient still has the "knot" on her head. Additional information has been requested.
Short of breath; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 13Mar2021 13:45 (Batch/Lot Number: EN6208) (at the age of 67 years old) as a single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient was taking concomitant medications. The patient previously took amoxicillin and had allergy to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. At about an hour after the vaccine on 13Mar2021 14:45, the patient started to be short of breath. It only lasted for about 20 minutes and then it went away. The patient went to the emergency room (ER) but by the time the patient was checked in, it went away. No treatment was received for the event. The outcome of event, short of breath, was recovered on 13Mar2021 15:05.  No follow-up attempts are needed. No further information is expected.
Over 3 days. Tdap given 06/04/2013 = L. deltoid. All lymph nodes swollen; nodes under (L) arm to (L) chest burning. Burning sensation. Neck stiff; All joints swollen. General weakness. Injection site mod. Redness/soreness. As of 06/19/20 still not feel 100% better.
First shot only chills and mild muscle aches gone by the next morning.  Second shot aftereffects were very different. Received the shot around noon on Tuesday , February 23, 2021. Later in the afternoon experienced muscle aches and chills. My head felt kind of weird. Hard to describe except I once had a morphine shot that made me feel close. I spent the next ~60 hours in bed. Fever, severe joint and muscle pain, migraine like headache, and brain fog is about all I remember. It could have been 2 hours or 60  hours, I don't remember. On Wednesday and Thursday my sedentary heart rate was 101 and 95 according to my Apple watch up from 77 on Tuesday. Couldn?t eat. Food tasted and smelled differently but not in a good way. Woke up this morning,Friday, with a mild headache and very fatigued but mostly back to normal.
Hemoglobinuria Reddish; body ache; chills; Fever; Pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBINURIA (Hemoglobinuria Reddish) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history), Cyst and Cyst removal.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection arm). On 30-Mar-2021, the patient experienced HAEMOGLOBINURIA (Hemoglobinuria Reddish) (seriousness criterion medically significant), PAIN (body ache), CHILLS (chills) and PYREXIA (Fever). At the time of the report, HAEMOGLOBINURIA (Hemoglobinuria Reddish), PAIN (body ache), CHILLS (chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection arm) outcome was unknown.        Anesthesia for surgery on index finger cyst on 02 Mar 2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-063819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063819:
Pt recvd 3 doses of Engerix-B 11JAN91; 14FEB91 & 18JUL91 It was determined that pt did not respond to vax series; it was determined that pt did not respond to vax series; 5th dose of Engerix-B was administered 10CT91;
Had severe nausea, vomiting, diffuse myalgias, neck pain, headache, and fever greater than 101 F.  Advised Motrin, Tylenol and rest.  Prescription for Phenergan given for nausea.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 030H21B, 016B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial did not undergo any temperature excursions.  No patient has reported adverse reaction.  No treatment medications were reported.
Patient states the injection site was inflamed the day after getting vaccine. Patient states the arm started swelling and getting bigger and moved from injection site to shoulder. Since the inflammation was getting bigger the patient was advised to go to the ER. The doctor states it could be an adverse reaction to vaccine or infection. If gotten worse then patient was prescribed an antibiotic to take.