chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important for the injection of injection site cellulitis. Information regarding PREVNAR 13 was received from a healthcare professional regarding an 18-month-old female patient who experienced localized redness and cellulitis at the site of administration of the PREVNAR 13. The patient received the first dose on 04-May-2010. The patient also received a dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (manufacturer unknown) on 04-May-2010. The patient was administered the PREVNAR 13 and DTaP in the same leg on 04-May-2010. After being administered the vaccine, the patient experienced localized redness in her leg. The next day, on 05-May-2010, the patient returned to the doctor's office due to an event and was diagnosed with cellulitis. Treatment included a course of unspecified antibiotic. It was reported that the events were due to PREVNAR 13 and not the DTaP because they knew where the patient was administered each vaccine and determined the causal relationship with PREVANR 13 based on the location of the redness and cellulitis. The events persisted. No additional information was available at the time of this report.
took a flu shot and got Guillen barre syndrome from it.; paralyzed from the neck down; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The case was reported by patient's daughter. The age at vaccination was not reported. The patient took a flu shot and got Guillen barre syndrome from it. He was paralyzed from the neck down. The physician told him never take another shot. The follow up was not required. This is 1 of the 9 link cases, reported by same reporter.
Information has been received from a pharmacist concerning an over 60 year old male patient with no known allergy who approximately 4 days ago (approximately on 21-OCT-2011) was vaccinated with a dose of ZOSTAVAX (Merck) (lot# unspecified). It was reported that on an unknown date, the patient had been diagnosed with an unspecified cancer. The patient had sought unspecified medical attention. At the time of the report, the unspecified cancer was not recovered. Upon internal review, unspecified cancer was determined to be other important medical event. Additional information has been requested.
Routine bloodwork showed that my white blood count was slightly elevated. Was sent to a Hemotologist, for further testing. My PCP diagnosed me with Hypothyroidism. I was put on Crestor and am curently waiting for my labs to come back.
Lips tingly, lips swelled, tongue tingly/numb, roof of mouth numb. Took 50 mg of Benedryl. Symptoms resolved within 20 minutes of taking meds.
A 41-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) via an unspecified route of administration on 23Mar2021 (at age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) on 02Mar2021 (at age of 41-years-old) as a single dose for COVID-19 immunisation. On an unspecified date, patient has welts on the arms and neck. Treatment received was diphenhydramine hydrochloride (BENADRYL) but they won't go away, she had been taking 1 capsule 25 mg once a day and now going to take 2 capsules because getting more welts and was scratching her arms. In addition, one day she woke up with a swollen left eye and the next day, the right eye too. At the time of reporting, the outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports sore arm 4 days after injection, later beginning to itch, red, swollen with small/fine bumps that spread under the arm and biceps.  Patient had poison ivy or poison oak on 12/31/2020. Taking prednisone and a cream on 1/4/21. She has used ice, benadryl, CBD cream, and slept.
10:20 AM: Within 10 minutes of vaccination, patient complained of itching arms and chest. Arms and chest had a non-raised lace-like rash. BP 128/90 HR: 99 Pulse Ox: 96. No wheezing, no shortness of breath Administered 100 mg pills Benadryl, po. Upon leaving, there was no more itching, rash or shortness of breath. Monitored for 30 minutes by EMS
This spontaneous report was received from a licensed vocational nurse referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (strength, dose, route, lot# and expiration date were not provided) for prophylaxis. It was reported that the vaccines were exposed to a temperature excursion between 44 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours and 45 min. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA012349:
This spontaneous case reported by a consumer, describes the occurrence of electrolyte imbalance  (low electrolytes) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022C21A) for COVID-19 immunization. Concurrent medical conditions included eczema (demographic skin) and multiple allergies. On Mar 8, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced electrolyte imbalance (low electrolytes). At the time of the report, electrolyte imbalance (low electrolytes) outcome unknown/not provided. Diagnostic results: On an unknown date, blood test: low electrolytes. No concomitant medications or treatment information reported. This case linked to MOD-2021-314919 (patient link).
9AM 27JUL95 call fr pt's mom stating pt had awaken fr night's sleep w/swollen tongue, hives on chest & red swollen inj site;2PM 27JUL95 call to pt, only c/o sore arm;
I developed hives.  Took OTC Zyrtec until i could see doctor.  Continue on zyrtec now but even with the zyrtec i am getting red lines that show up randomly and move around different parts of my body.  They do not itch but it could be the zyrtec helping that issue.  They are no longer raised but again the zyrtec could be helping that.  Doctor said he wasn't sure what was causing it, could be the vaccine, so he suggested i wait and see if it resolves on it's own.  I saw him on 11/17/21.  It has not resolved as of today.
Mother states that patient had been playing around the house. She noticed that her daughter started turning red with a rash all over her body with swelling in both eyes.
Headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an intramuscular route of administration in the left arm on 26Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included paroxetine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); for unknown indication from an unknown date and unknown if ongoing. The patient previously took cefaclor (CECLOR) and amoxicillin / clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an intramuscular route of administration in the left arm on 29Mar2021 at 15:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 12:00, the patient experienced headache, fatigue, muscle aches. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. 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 headache, fatigue, muscle aches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer (the subject's mother) and described the occurrence of off label use in a 2-month-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.   On an unknown date in 2009 the subject accidentally received 1st dose of HAVRIX (details unknown) at 2 months of age instead of PNEUMOCOCCAL vaccine (wrong vaccine administered).  The subject was younger than the recommended age of administration for HAVRIX (off-label use).  Less than one year after vaccination with HAVRIX, the subject experienced tension in arm, bright red face, breath holding, grunting, pain, change in sleeping pattern and temper tantrums.  After receiving HAVRIX, the reporter noticed her daughter would tense her right arm straight in the air and get frozen in position.  At the same time her daughter's face would get bright red and she would hold her breath and grunt like she was in pain.  The reporter states she can help her daughter relax her arms by stretching her out and then the facial redness goes away after she relaxes.  She also states her sleeping pattern has changed.  Prior to receiving the vaccine she slept well but now she does not sleep well at night or during the day.  She is not sure if she relates the sleeping pattern change to receiving HAVRIX or just her being an infant and having sleeping pattern change all the time.  The physician told her he felt the tensing episodes were the beginning of temper tantrums.  She states at first they noticed these events occurring when she was tired but they have gotten worse and more frequent.  At the time of reporting the events were worse.  At the time of reporting the subject was 4.5 months old.  The reporter did not want to provide any further details at this time.
This spontaneous report as received from a physician via medical records through Pfizer (manufacturer control #2017086232) refers to a currently 57-year-old female patient. No information on the patient's concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), reported as "pneumococcal polysaccharides". The outcome of the event was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. All available medical records will be provided upon request. Additional information has been requested.
At approximately 4:58 PM on 03/31/2021 patient during 30 minute observation developed dizziness, general itchiness and urticaria to his hands. Pt administered in RA IM 50mg Benadryl at 5:00pm. Pt AA&Ox4, airway patent,  breathing normal and non-labored. Pulse strong and regular with adequate perfusion. Pt lung sounds clear upper and lower lobes. Pt stated improvement, and intially refused transport to the ED, when upon sitting patient felt profound dizziness without syncope and patient was consulted again about emergency transport, who consented. Pt transported via emergency services to Hospital. First and last vitals as follows: 4:50pm 160/100bp, 122p, 22r, 98% O2  5:20pm 152/92bp, 110p, 20r, 98% O2
Pt came in for TDAP 7/5/22, pt was bit by rooster, pt states that most of the liquid ran out of her arm and pt concerned she did not get full vaccine.
Information has been received from a physician referring to an unknown number of unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 30-JUN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M014544 with expiration date 27-NOV-2017, lot # L048857 with expiration date 15-OCT-2017; dose unknown; oral). It was reported that the vaccine was improperly stored at 34.4 Fahrenheit (F) for 18 minutes and at 51.5 F for 2 hours 50 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was brought to the ED as a special response from Covid vaccine clinic for possible allergic reaction Patient is currently receiving her second Covid vaccine She subsequently developed left arm droop Lethargy Nausea She does have a known history of anxiety She also stated that when she received her first Pfizer Covid vaccine she has similar symptoms She denies of any shortness of breath Denies any facial swelling lip swelling Denies any chest pain or palpitation Denies any abdominal pain She was previously seen by her doctor regarding the reaction Her doctor stated that she might of had a vasovagal versus acute anxiety attack Headache
Redness, warmth, swelling at injection site; fever of 101 degrees F.
This spontaneous report as received from a registered nurse refers to an approximately 9 years old female patient with no pertinent medical history and no drug reactions/allergies who was vaccinated with the first dose of VARIVAX on an unspecified date in 2001. There was no concomitant medication. On an unspecified date in 2010 the patient developed the shingles. The patient sought medical attention by office visit. No lab diagnostics studies were performed. The outcome of shingles was unknown. Additional information has been requested.
2nd dose given days before 6 months; This non-serious case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 24-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   Previously administered products included Havrix 1440 (2nd dose was given before 6 month.).   On 12-APR-2023, the patient received the 2nd dose of Havrix 1440 adult (intramuscular). On 12-APR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given days before 6 months). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date 11-MAY-2023 The patient received 1st dose on an unknown date. 2nd dose was administered before completion of 6 months from 1st dose. No reaction was reported. The reporter consented to follow up. The patient received the two dose of Hvirix less than 6 months of time period, which led to drug dose administration interval too short. This case is linked with US2023061660 case, by same reporter.; Sender's Comments:  US-GSK-US2023061660:Same reporter, different patient
He got his vaccine, his pulse went from 42-133 within a couple of hours following the vaccine.  He had no pain the day of the shot, the 2nd day his whole right side of his body he could not move, his hip and spine pain was horrible.  He called his doctor, he told him he was having an AE to the vaccine, and that it would go away.  He said that the booster aggravated his diverticulitis he just had gotten over.  He then started getting acne on his face, but went away.  On 1/7/22 he fell asleep 4 separate times for no reason.  He woke up at 6:00 AM, fell asleep again at 9:06 AM.  Then his heart rate would not drop, had 12 high heart notifications while he was sitting there and pulse over 100 for 10 minutes (11 episodes).  6 days after the booster he got up at 6:00 AM, fell asleep again for no reason at 8:38 AM.  He was basically bed ridden on 1/7/22.  On 1/13/22 he woke up at 6:00 AM, fell sleep again at 2:24 PM, which is not usual for him.  On 1/14/22 he woke up at 5:30 AM, and fell asleep on 9:34 AM.  10 days after the shot he was getting 50 point swings in his BP.  On 1/18-19 he woke up at 6:20 and fell asleep at 9:43 AM, and then asleep at 10:00 AM, deep sleep when he has this.  Then near the end of the month his BP was 211/121, which happens almost every day now since the vaccine.  His doctor tried to take him off medicine to see if that affecting it, but that did not change anything.  States it's almost like the booster took out all the medicines that he takes for his other conditions.  On 1/23/22 he woke up at 6:00 AM, fell asleep for 35 minutes at 9:05 AM.  Since the shot his average BP has gone up to averaging 189/111.  He gets dizzy because of these high heart rates and BP.   His heart rate has gone up 51 points, and has pain all over his body.  His medicines were increased.  1/26/22 his HR went from 91-156 under 2 minutes and his feet turned blue.   1/26/22 he woke up at 5:15 AM, fell asleep again at 2:02 PM.  On 1/27/22 still getting 43 point swings in his pulse.  His heart is all over the place, his sleep is erratic.  On 1/28/22 his BP was 209/123.  He has shortness of breath, can't catch his breath.  All of these symptoms still continue.  His doctors are hoping it will go away, and on some days it is better than others.  His BP last night was 208/122.    He has horrible brain fog, fibromyalgia pains have come back, can hardly walk up and down the stairs due to the pain, and he has pain that feels like his back is ripping out, migraines that wake him up at night.  His doctors believe that the shot overloaded his symptoms and activated his fight or flight system, and are hoping that over time it will improve.  They basically have told him there is nothing that they can do for him other than wait it out.    He took his pulse went from 73-123 and being on the maximum dose of his medication to treat him for his POTT's and other symptoms.    He would be very hesitant to get any more vaccines due to this and does not want anybody else to have the same problems.
short lived axillary adenopathy; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 72 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Adult onset atopic dermatitis", start date: 01Jan2012 (unspecified if ongoing), notes: Pertinent details: Treated with narrow beam UVB. Concomitant medication(s) included: TRIAMCINOLONE; CETAPHIL [CETYL ALCOHOL;SODIUM LAURYL SULFATE;STEARYL ALCOHOL]. Vaccination history included: BNT162b2 (Dose: 1st, Date: 11Jan2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 11Jan2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "short lived apillary"; BNT162b2 (Dose: 2nd , Date: 04Mar2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "1st dose: 11Jan2021; 2nd dose: 04Mar2021". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "short lived axillary adenopathy".  Additional information: Only side effect from vaccine was short lived apillary adenopathy or the side of the injection.; Sender's Comments: Linked Report(s) : PFIZER INC-202300066370 same patient and event, different dose number.
Ringing in ears, primarily the left ear. Saw an ENT on 8/17/21. Diagnosed as tinnitus.
Chills, shaking, body aches, fever started at 8;00pm then lasted all night. Woke up with body aches, headache  and a fever. Body aches all day.
8NOV91 TC from mom 11AM pt not sleep all night c/o pain in leg & knee; mom has not looked @ injec site "pt won't let me" has not taken temp; Pt had 2 doses of chewable APAP yesterday;
Rash down both arms, itch at times  and continuing as of today 3/20/2021.  Raised bumps and noticeable Ed ness down the inside of both arms...none apparent elsewhere.
fatigue; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and AMLODIPINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, MYALGIA (muscle pain) had resolved. At the time of the report, FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include airborne vitamins.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.