chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Dtap/IPV component of Pentacel instead of Quadracel/ no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (5th dose) instead of QUADRACEL lot UI952ABA (Expiry date 30-Jun-2020) via intramuscular route in the left deltoid on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included INFLUENZA VACCINE (INFLUENZA VACCINE), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error case due to wrong vaccine administered.  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.
Information has been received from a registered nurse (R.N.) concerning two or three patients who were vaccinated with VARIVAX (Merck) that was stored improperly. The vials of VARIVAX (Merck) were stored in the freezer with 8 degrees Fahrenheit for one month. No adverse effect reported. No product quality complaint was involved. Follow-up information was received from a registered nurse (R.N.) concerning a 48 month old male with no drug allergies and with birth weight of 7 lb 5 oz and 1 sibling who on 08-AUG-2008 was vaccinated with the second dose of VARIVAX (Merck) in the thigh (lot # 658763/1341U). On that same day, secondary suspect therapy included MMR II (MSD) (lot # 654895/0745U). Other concomitant therapy included DTaP (lot # AC14BB661AA) and POLIOVAX (lot # AO126). There was no illness at time of vaccination. On 10-AUG-2008, the patient experienced red, swelling, tender at injection site. Subsequently, the patient recovered. No lab tests performed. Additional information is not expected.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature  of 30.2F. On 01-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported0. There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 12 month old patient who was vaccinated with a first dose of rotavirus vaccine.  No product quality complaint was involved. No other information was provided.  Additional information has been requested.
symptoms started residing except for a little numbness in her lips; lips and tongue went numb and she had some trouble swallowing but no trouble breathing; lips and tongue went numb and she had some trouble swallowing but no trouble breathing; symptoms came back and she experienced tingling in her lips; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), DYSPHAGIA (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), PARAESTHESIA ORAL (symptoms came back and she experienced tingling in her lips) and HYPOAESTHESIA ORAL (symptoms started residing except for a little numbness in her lips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), DYSPHAGIA (lips and tongue went numb and she had some trouble swallowing but no trouble breathing) and PARAESTHESIA ORAL (symptoms came back and she experienced tingling in her lips). On an unknown date, the patient experienced HYPOAESTHESIA ORAL (symptoms started residing except for a little numbness in her lips). On 03-Mar-2021, HYPOAESTHESIA ORAL (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), DYSPHAGIA (lips and tongue went numb and she had some trouble swallowing but no trouble breathing) and PARAESTHESIA ORAL (symptoms came back and she experienced tingling in her lips) had resolved. At the time of the report, HYPOAESTHESIA ORAL (symptoms started residing except for a little numbness in her lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient herself took Benadryl for treating events.
I had the usual side effects, sore arm, fatigue? then 2 days after the vaccine I had a panic attack, then continued to have them along the week. I believe that on the 17th I was taken to the ER with high heart rate, chest pain, tremors? but doctors ran test and believed to be another panic attack, they referred me to a doctor. The past month ive been struggling with extreme anxiety and panic attacks, ive been on escitalopram, weekly therapy. I had no prior history with mental illness.
INJECTION SITE HAS ATROPHIED MUSCLE, A DEPRESSION 1.5 INCHES WIDE AND 2 INCHES TALL HAS DEVELOPED.  DEPRESSION IS ABOUT 1/2 TO 3/4 INCHES DEEP.  ONE HALF INCH BELOW THE INJECTION SITE IS A KNOT.
About a week after my first vaccination shot, I had an oral herpe breakout (bottom lip).; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on May2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. The facility in which the vaccination was administered was a hospital. Medical history included seasonal allergy from known Seasonal allergies, lactose intolerance from Known allergies, anxiety, depression from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride, phentermine resin and vitamins. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23May2021 19:00 about a week after her first vaccination shot the patient experienced an oral herpes breakout. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot Number: EW0178) dose 2 via an unspecified route of administration in the left arm on 02JUN2021 at 14:15 (at the age of 38-year-old) as a single dose for COVID-19 immunization. The event did not result in doctor office visit, emergency room. Therapeutic measures were taken as a result of event and included treatment with docosanol 10%. The clinical outcome of the event was resolved on an unspecified date of 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
INITIALLY PATIENT EXPERIENCED EXTREMELY SEVERE HEADACHE WITHIN 10 MINUTES AFTER RECEIVING THE J&J VACCINE ON 5/26/21, AND ALSO STATED THAT IT FLARED UP HER FIBROMYALGIA. SHE began HAVING TROUBLE WITH BALANCE,  FOCUS, AND MOSTLY NEUROLOGICAL PROBLEMS WITHIN A WEEK AFTER RECEIVING J&J VACCINE AND STILL CURRENTLY OCCURING. PATIENT IS VERY CONCERNED.
Got the 1st dose of Covid vaccine on 1/8/21.  Left arm was sore  and have a swollen lump but it is a common reaction.  Left arm stop hurting after 1 day but the lump is still there.  On 1/12/21,  I start noticing my underarm starting to hurt.  I thought I pulled a muscle or maybe a swollen lymph node. Did a self examination no swollen lymph so I thought it was a pull muscle. Been taking Advil twice a day but now it is the 1/14/21 underarm still hurt and the lump on the left arm is still there and slightly swollen now. Still taking Advil twice a day due to left underarm pain.
Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is a spontaneous report from a contactable other Health Professional (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 18Jan2021 08:15 at single dose in left arm for COVID-19 immunization. Medical history included non allergic rhinitis and vestibular migraines. The patient had not known allergic, but very sensitive to SE. Concomitant medications included "sensimist", naproxen sodium (ALEVE), progesterone, estradiol. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 28Dec2020 08:45 at single dose in left arm for COVID-19 immunization. No other vaccine was received in four weeks. The patient experienced roscia-major flare occurred in eyes within 2 hours of second vaccine on 18Jan2021 09:00. Continued to worsen over next 24 hours. Necessitated a trip to eye dr. Have never had a flare this serious. In addition, severe itchiness day vaccine given. Took antihistamine (Allegra) second day which solved issue. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received Neomycin & Polymyxin B Sulfates & Dexamethasone Op as treatment. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Pt recvd 3 doses  of Engerix B according to 0, 1 & 6mos schedule. 28Nov91 it was determined that pt did not respond to the vax series.
c/o pain, discomfort & swelling lt shoulder w/erythema, warm to touch & feeling very sleepy & tired;tx apply heat & take Viox;
Got sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Got sore arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Guillain-Barre syndrome (Guillain-Barre syndrome was diagnosed 4 years ago).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Got sore arm). At the time of the report, PAIN IN EXTREMITY (Got sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2021-058132 (Patient Link).
Cough; Feeling under the weather; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, "What I was trying to find out. I tried as they say make a long story short here. I just got the shot (Unspecified Shot) a couple days ago. It was not really (incomplete sentence), it was to do with the shot or not? So, this was the question. I was not feeling under the weather before I got the shot, but I started to have little bit of cough since then and my daughter has not feeling well also (Further clarification was unknown if daughter had the shot or not, hence split case was not made). She finds out that the young lady she works with her family were in (state), so we were in area that had a high number of cases, her family had contracted the virus (Further clarification was unknown), so meaning that my daughter was exposed, my daughter was exposed probably a week or so, with my daughter was going to get a couple of rapid tests to make sure she was positive or negative. Now I had someone tell me, I understood that this shot did not had the live virus in it, I understood that already, just to tell you, I know that part, but this was the question someone (incomplete sentence), I did not know if this was true that was why I was calling Pfizer. Someone told my daughter because that I had my first shot a couple days ago that I might, (incomplete sentence) if I tested right now (distorted voice) even if it was 'far'. My question to you, was that true, should I go ahead and take a test anyway to see if it tests positive or should I be sure it may be nothing. I did have a shot couple of days ago." The clinical outcome of the events was unknown at the time of report.  Information about Batch/lot number has been requested.
Diagnosed cellulitis of left thigh. Treated with Augmentin 400 po BID x 5 days, ice to area.
Information has been received from a health professional concerning a female who was IM vaccinated with all three doses of GARDASIL (lot numbers unspecified). Subsequently after each dose, the patient experienced a headache that lasted all day then resolved. Additional information has been requested.
Sometime in May 2022 I woke up with the whole room spinning. In September I noticed I had changes in my vision and unable to focus and felt faint. They continued to get worse. Along with this I had blurry vision, confusion and feeling concussed. I fainted on October 24, 2022, and I went to the emergency department. Two days later my instability got worse, so I returned to the emergency department. Since I was not life-threatened I was released due to COVID-19 cases in the hospital. Since then, my symptoms come and go. I don't have vertigo. I had an EEG and was negative. On February 20, 2023, I got dizzy and ran into my shower door. The next day I went to the emergency room again on February 21, 2023, and stayed in the hospital one night. The emergency department states that I have syncope vertigo.
she feels like her toes are numb,; This is a spontaneous report from a contactable consumer or other non-HCP. A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 21Jul2021 as DOSE 2, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jul2021, the patient experienced she feels like her toes are numb. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vax. at worksite, continued at job, 3 1/2 hrs. later felt like throat had something stuck in it, felt constricted. Tongue felt tingly and thick. Felt flush, skin on chest, legs & arms was mottled, but not described as hives. Left arm at
Patient felt fatigued and noticed blood sugars were in the  200's after receiving his first dose of the COVID-19 vaccine. He received  the second dose with no reported issues.
Pt had no issues yesterday after vaccination.  However, pt stated both thighs felt heavy and stiff "like elephants were sitting on them" this morning when she woke up.
Patient reported tinnitus in right ear after receiving first dose. Has not resolved 8 months later
Itchiness; Redness; Swelling; A spontaneous report was received from a consumer concerning a female patient (age: unknown), who received Moderna's COVID-19 vaccine (mRNA-1273) experienced redness, swelling and itchy.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) for prophylaxis of COVID-19 infection along with her husband and two coworkers.  On 16 Jan 2021, the patient experienced redness and swelling which was resolved on 20 Jan 2021. Again, on 24 Jan 2021 the patient's hand was red and itchy. Treatment for itchiness include Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of events, redness, swelling and itchy was not resolved.
Right after I got it, my heart started to beat really fast and I got hot. I called my doctor and he told me to make sure that I'm limiting caffeine. I noticed that it's still happening off and on, so he's ordering a Holter Monitor. Currently waiting for approval to have it done.
Patient at 18:36 experienced a 1839 Syncopal episode 5-10 seconds, during 15min observation period. While seated patient eyes rolled back, and fell out of his chair onto his left side onto the floor, face down. Patient rolled over, semi-conscious, some- what confused at this time.   PCP and RN coordinator assessed patient. Irregular Pulse 48 noted, B/P 130/80 SPO2 88-90%. Patient extremely pallor but responsive. Confusion cleared after 5 minutes. Followed up vitals: Pulse 60 noted, B/P 128/86. Patient was walked out to vehicle.
Within a few minutes, increased salivation; Metallic taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 01Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, spontaneous coronary artery dissection (SCAD) , trigeminal neuralgia, sulfonamide allergy, pollen allergy, dust allergy, allergy to feathers and allergy to animal hair. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, within a few minutes, the patient experienced increased salivation and metallic taste in mouth that lasted 24 hours. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased salivation and metallic taste in mouth was recovered on 02Mar2021.   No follow-up attempts are possible. No further information is expected.
Per mom: Itchy, red rash under neck, on abdomen, under arms and back of knees. Appeared within 24hrs after vaccines administered. Pt saw PCP who prescribed rx for reaction.
Sore Throat, unproductive cough, difficulty breathing. Had worked the night shift and went to the DR right away after work.
There was a little soreness and redness. A couple days after my heart started racing and it got worse. I went into Afiv and was hospitalized for 3 days. I had my heart shocked three times to get it into rhythm.
On June 26, 2021 that evening I went to lay down and it felt like I had pulled a muscle on my left side and I couldn't catch my breathe. I was out of town and couldn't go to the doctor. So when I came home on June 27, 2021 I had to call 911. The EMS check my heart and it was fine. I decide to wait till the morning to go to urgent care on 6/28/2021. I was still in pain on 6/29/2021 . Urgent care sent me for a chest X-ray and on the 6/30/2021. So when they said that they couldn't see my lungs and Urgent care told me to go to the ER. An the ER doctor admitted me. I spent 9 days there. I end up having surgery on my left lungs on 7/2/2021 and they put a test tube in for drainage. They remove the test tube on the 07/06/2021 and I was discharged on 07/08/2021 with antibiotics and a home nurse that comes once a week. I had a picc line inserted for the antibiotics.
Woke up at 2AM with full-body aches and chills, nausea, headache. Alternating hot and cold, and muscle weakness.  Patient blacked out twice, at 2:30 and 8:30 AM, for approximately 20 seconds each time. Temperature was slightly elevated at 99.1.  Currently (11 AM) patient is sore and feeling feverish, with a headache.
Moderna COVID-19 Vaccine EUA  A week after the vaccine I had swelling and itching at the site of the injection
8AUG96 achiness of lt shoulder lasting 2hr;9AUG96 retired 11PM, awakened 10AUG96 430AM went to bathroom, returned to bed feeling lightheaded, returned to bathroom, passed out, hit chin & recv 4 stitches to close laceration;
Extreme pain on both side of right arm (site of injection) from shoulder to elbow, 24 hrs. Pain bad for 4 days. Could not lift arm at all 3 days. Manageable pain for 3 days of a week after shot. Almost back to normal 1 week and 2 days after shot. Complete loss of arm function for 4 days.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of VARIVAX (lot # N022996, expiry 23-AUG-2018) (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute VARIVAX was properly stored. The administered doses of the VARIVAX experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930; US-009507513-1811USA010213: Original Case: 1811USA010211; US-009507513-1811USA010214: US-009507513-1811USA010215.
Initial 48 hours of fever, chills, fatigue 1-2 weeks post injection, Bell's palsy on left side of face 4+ months (enduring), fatigue, joints ache (hips, wrists, elbows, shoulders)