chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after being vaccinated, pt started to shake and was told to lie down. Staff started to take vital signs. During examination, stridor was noticed by staff and pt confirmed shortness of breath. Epi pen and 50 mg of IM Benadryl was administered. Stridor continued but pt started breathing easier. Staff continued to take vitals and observe pt until ambulance arrived.
have boils on my face; at the area injected at oral commissures looks like fat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-062922-16304.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66  for covid-19 immunisation; hyaluronic acid (RESTYLANE), in Jan2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "at the area injected at oral commissures looks like fat"; FURUNCLE (non-serious) with onset 2022, outcome "unknown", described as "have boils on my face". Therapeutic measures were not taken as a result of oral disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Case Detail Report: Galderma Reference Number: GL-062922-16304 Patient Identifiers: As (DOB withheld) 67-year-old male HCP Contact Information: (Name withheld) (patient reporter) (email and phone number withheld)  Reported Adverse Event Per Consumer (speaks only Spanish) Visited the Dermatologist and she injected Restylane this was done the end of Jan2022. Every place she injected the product I have boils on my face. Injector: (Name, address and phone number withheld). Event date: Either the end of Jan2022 or beginning of Feb2022  Event: Boils in face where injected - and at the area injected at oral commissures looks like fat. Event began immediately after injection of Restylane Contour to my cheeks and Restylane Refyne to my nasolabial folds and oral commissures. I was very unhappy with results, so six days after she injected me, I went to the office and saw her. She took before and after pictures, but they were from far away-not close up.  Treatment instructions: She told me it was a normal process. She did not treat anything. She asked me if I wanted more filler injected instead. I sent her (doctor) at least four or five emails. She wrote back but gave very simple answers. Patient had Pfizer Covid-19 vaccines on 25Feb2021, 18Mar2021 and a booster on 01Oct2021. Patient uses no other medications.  Follow-up (01Jul2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Updated Information: Patient information (DOB, age added).  Additional Information: Query: Could you please help provided correct DOB since incorrect format was provided. Response: Our apologies, the correct DOB is (date withheld).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient already had 2 Primary series of Pfizer vaccine  (11/23/21 & 2/25/22), and was given a primary dose of Moderna.
Pain in the back of the knees, Dr scheduled ultrasound to check for blood clots.
nerve issues; cold feels in neck, arms and back.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on 21May2021 as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced fatigue. On an unspecified date on 2021, 5 weeks after vaccination, the patient experienced cold feels in neck, arms and back. The patient Describes it as nerve issues. The patient stated "Mint fall" on her arms, neck and back which she never had before while she was walking her dog and was still going through it. The patient wanted to know if this was coincidental. HCP indicated could persist up to six weeks. The outcome of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Possible administration of expired Vaccine; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced possible administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible administration of expired vaccine was not reported. This report was non-serious.
Employee received vaccine 11-30-12. Informed Emp. Health nurse 12-6-12 that she went to ER on 12-2-12 at 6 p for symptoms she developed at 5 p same day. C/O chest pain, abdominal pain, hoarseness, sore throat, high B/P reading, (R) leg weakness, shaky feeling. No increased temperature.
Patient was vaccinated and within 10 minutes bilateral hands became swollen with chest tightness. Patient was given 100mg benadryl po and within 15 minutes her symptoms diminished. at 1700 when speaking with patient she denies any symptoms.
Pt exp erythema, edema, warmth & pain following immun; Tx DPH & hot compresses; Resolved w/in 48 hrs;
Chest pain, thightness in chest, saw cardiologist had stress test 3-1021 10:00Am had to have stent placement in LAD Mode on 3-12-21
Right thigh redness, swelling. Diagnosed cellulitis in E.D. given KEFLEX and recovered. Note patient given PEDIARIX instead of DTaP as indicated.
Immediately following the vaccines administered on December 1, 2017 we noticed our son was sleeping more, developed a rash, rosy cheeks and a fever and ear infection that lasted two weeks. Shortly thereafter he stopped talking and refusing to eat. In February 2017 we noticed no signs of improvements and made an appointment with his pediatrician to address our concerns. Appointment made for March 9, 2017,
area where the shot was given has become swollen, red, and hot - It is roughly the size of a fifty cent piece in diameter.  Sweating.  Chills, Fatigue, feeling extremely hot overall
COVID-19 virus test postive; COVID-19 virus test postive; fever; tiredness; feellng bad; Interchange of vaccine products; Offlabel use; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 20220122896 (janssen).  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (ADALIMUMAB), subcutaneous (Batch/Lot number: unknown) till 20Dec2021 for colitis ulcerative. Relevant medical history included: "Moderate to severe ulcerative colitis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 01Apr2021, for COVID-19 immunisation; Janssen covid-19 vaccine (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 03Jan2022, outcome "recovered" (Jan2022), DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown" and all described as "COVID-19 virus test postive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 01Oct2021, outcome "unknown", described as "Offlabel use"; PYREXIA (non-serious) with onset 03Jan2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 03Jan2022, outcome "unknown", described as "tiredness"; FEELING ABNORMAL (non-serious) with onset 03Jan2022, outcome "unknown", described as "feellng bad". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Shortness of breath, apneic spells while feeding; developed seizures within 36-48 hours after admission.
Reaction started 9/22/18 right leg started with a lump, red and hot. Parent applied cold compresses. Then rash stated on right leg then spread to the left leg and abdominal area.
Rash on hands, feet and scalp 24 hrs after receiving vaccine. No other symptoms.
following vax pt exp local swelling @ the inj site & swelling of the ear on same side;sx lasted 5 days & resolved;
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 50-year-old male patient received BNT162b2 (BNT162B2), on 28Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Apr2020; LOSARTAN, start date: 01Apr2020; ATORVASTATIN, start date: 01Apr2020, stop date: 22May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2023) Positive; (25May2023) Negative.Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 22May2023 to 26May2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207996 same patient, different product/event;
Her close up vision has gotten progressively worse; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (Her close up vision has gotten progressively worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (The patient has myasthenia gravis that just affects her eyes. for treating that disease, she gets infusions every 28 days, and the day before getting the vaccine, she received one.). Concomitant products included FLUTICASONE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (Her close up vision has gotten progressively worse). The patient was treated with OMEPRAZOLE at a dose of UNK dosage form and ALPRAZOLAM at a dose of UNK dosage form. At the time of the report, VISUAL IMPAIRMENT (Her close up vision has gotten progressively worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
GBS post flu vax; pt recvd flu vax 1NOV94 & had a gradual onset of extremity weakness, lower>upper; pt seen by MD 14NOV w/weakness (0/5) in both lower limbs & extreme weakness in upper extremities; hyporeflexive also; PT in nearly 2mo hosp
Pain, swelling, redness and itching at the injection site approximately 24 hours following administration.
I am a pharmacist with 17 years of clinical experience and so medically literate. The night of the vaccine I had severe heart palpitations that woke me every 2 hours, but I managed to get some sleep. The 2nd night I could not fall asleep at all. I stayed up all night. 2nd night tried melatonin and benadryl, and only manged to sleep 2 hours very late in the night. This went on for a week. I saw a doctor and was given trazodone. It helped fall asleep but kept waking up every hour or 2 and then trouble falling asleep afterwards. So only managed 3-4 hours of sleep each night. I had side effects from Trazodone with mood changes so had to stop taking it. I saw another doctor based on a friend's recommendation who was going through the same issue. I was prescribed clonazepam 1mg. I was finally able to sleep a full night. I took it for 7-10 days and tried to taper back since I did not want to be dependent on it and wanted to go back to sleeping without  any sleeping aids. Klonopin 0.5mg seemed to be helping so on a follow-up appointment, I was given a months supply of clonazepam 0.5mg. I took that for a week and tried to taper that further and that did not help with sleep.  Amidst of this I started having tinnitus in the right ear and I never had tinnitus before. I don' t know if it was triggered by sleep deprivation, the vaccine or the clonazepam.  But I stopped taking clonazepam altogether after 3 weeks.  9 weeks out since the 1st dose and I can sleep a little on alternate nights only. And that sleep is fractured. So one night of almost no sleep and one night of 3-4 of hours of sleep if lucky. I tried benadryl and it helps a little but the trouble falling asleep is just as severe and continue to wake up every 2-3 hours. 8 hours in bed and only manage 3-4 hours of sleep. I skipped the 2nd dose due to continued issues with sleep. Looking for answers and guidance on how best to treat this and if/when this will be over for me.
headache; my body was drained like really tired; slept all day; This is a spontaneous report from a non-contactable consumer communicated to Pfizer. This consumer reported.  A patient with unspecified age and gender received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced headache and her body was drained like tired. she didn't go to work Wednesday. The patient slept all day. On Thursday she felt much better and rested and went to work. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.
Day later leg per Mom swollen and pt limping on 1/29/03 in Hlth dept . L leg swollen in thigh to knee, warm to touch.
Patient experienced shoulder pain.  No treatment was needed.  This was possibly due to injection given too close to the acromion process.
have a full blown case of shingles. I have to go to an eye doctor now because it's in my eye; full blown case of shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, after receiving vaccine had a full blown case of shingles. The shingles was in eye.
Client claimed she received the vaccines too high near her shoulder that is why she experience mild pain right away but ignore it then after 2 days the mild pain become moderate like 6-7 scale out of 10 but on and off it comes away then since 10/24 /19 up to present - pain worsen  and she had issues with limited mobility only on site where she got the immunization (left shoulders as per client) that opt her seek medical attention through her PCP and later diagnosed that it was flu vaccines related.
FLUZONE HIGH DOSE was given to a person 60 years of ago. Wrong dose-over dosage.
Headache, fever, fatigue, nausea, achy, shooting pains, chills
Patient developed a bulls eye rash on left deltoid. It is itchy according to patient. Patient was instructed to inform MD. No treatment was suggested. No outcome has been established yet.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 to 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Case completed Pfizer Covid series on 3/4/2021, then was admitted to hospital on 8/6/2021 with Covid contributing to exacerbation of her co-morbidities.
PATIENT WAS SEATED AND GIVEN VACCINE AND PASSED OUT IMMEDIATELY.  PATIENT REGAINED CONSCIOUSNESS A FEW MOMENTS LATER.   PATIENT WAS MOVED TO THE FLOOR IN SUPINE POSITION WITH LEGS ELEVATED.  PATIENT STAYED CONCIOUS AND RECOVERED IN 20-25 MINUTES.   BLOOD PRESSURE WAS 122/78, PATIENT REMAINED AWAKE AND ALERT.  PATIENT LEFT STORE UNDER HIS OWN POWER WITH HIS SPOUSE.
Patient Received 0.5mL Flulaval in left deltoid at 12:45 PM. 1:15 PM one of patient's friends states that patient was feeling dizzy. Nurse spoke with patient and stated was feeling a little dizzy and shaky but no complaints of swelling in the mouth or throat or shortness of breath. BP 117/76, P 72, R 21. 1:30 PM patient said still feeling a little dizzy and shaky and at this point did not feel the need to seek medical attention. Patient added that his shift was over at 2:00 PM and he would be going home and would seek medical attention if still felt dizzy.
Low grade fever 100.5; Fatigue; This case was reported by a physician via sales rep and described the occurrence of fever in a 56-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, 1 day after receiving Boostrix, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were unknown.   It was unknown if the reporter considered the fever and fatigue to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and had low grade fever of 100.5 degree F and fatigue.
Swollen lymphnodes under armpit (golf ball size) and low grade fever, body aches, injection site redness and pain in arm.
got the vaccine and 6 months later got the shingles/ suspected vaccination failure; got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's sibling. The age at vaccination was not reported. The reporter stated that, the patient got the vaccine and 6 months later got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.