chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-JAN-2018, the patient was inadvertently vaccinated with a fourth dose of ROTATEQ per oral, lot # N012757 with expiration date January 2019, for prophylaxis at the patient's 1 year checkup. No adverse effects were reported in the patient. The physician stated that the initial three doses were given at the appropriate intervals stated in the prescribing information.
Redness and swelling noted from shoulder down arm 6". Warm and tender to touch. Afebrile.
Soreness and pain with some movements in left arm from deltoid/bicep area down to hand. At first I put this off as a side effect of the vaccination, but it never got better! Weakened grip, painful arm movements, painful to carry items, painful to lift, extend and flex. Painful to rotate lower arm.
Headache & Fever Narrative:  Fever 100.1; Chills; Migraine
10 hours after vaccine, very short of breath. Vaccine site very sore, red and bruised, entire upper arm.  Paramedics called, not transported to hospital. Advised to not take 2nd dose.  Benadryl given orally.
first dose on 17-JUL-2021, second dose has not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 17th July 2021).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that the patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter stated that the patient was not immunocompromised. No further information reported. The reporter did not consent to follow-up.
Extreme Pulsatile Tinnitus started in the right ear after the vaccine. Then loss of equilibrium and vomiting that led to overnight hospitalization. Hearing loss in right Ear and vertigo still present.
Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 87.46  Concomitant products were not provided.  On 17-Feb-2021 vials were moved to clinic. On 11-Feb-2021 the vaccines were moved to fridge. 17-Feb-2021, the vial underwent the excursion on the following timings: at 08 AM temperature was 20. The vaccine beyond use date was reported as 13-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
12 DAys After Covid VAccine duRing tennis game became nausea, pAle, shaky, disoriented, felt like Ready to pass out 14 dAys After nasuea, sAW yellow spots, felt ready to pass out
stroke; Trouble speaking; Terrible headache; A spontaneous report was received from a reporter like a consumer concerning an 84 year old male patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible headache/ headache, trouble speaking/ speech disorder, stroke/ haemorrhagic stroke.  The patient's medical history included stroke and prior stress test on 10 Feb 2021. Concomitant medications were not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position for prophylaxis of COVID-19 infection.  On 11 Feb 2021, patient experienced a terrible headache and was having trouble speaking. On 12 Feb 2021, the patient was told at the hospital he had a stroke. He was told that the bleeding was in the same place of the previous stroke.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's advanced age and prior history of stroke may have been contributory.
Event:  received my 1st shot of Pfizer vaccine on 04/18/2021.  Subsequently experienced the onset of the rash on 04/23/2021.  Onset of the rash was in my left shoulder blade.  Quality of the rash includes burning discomfort and pain, limited itching.  Over the course of the next few days,  started experiencing the rash migrate across  shoulder and into  left anterior axilla.  Treatment: valACYclovir (VALTREX) 1000 MG tablet; Take 1 tablet (1,000 mg total) by mouth 3 (three) times daily for 7 days.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age who on 10-JUL-2012, was inadvertently vaccinated with a dose of VARIVAX subcutaneously, instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
I noticed tinnitus the night after my second vaccination.  It progressed over the next two weeks causing me to eventually seek treatment.  I now see online that this could potentially be reversed with immediate treatment.  Please recognize and educate about this reversable side effect so people do not suffer permanently and can continue to get future vaccines.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 30-SEP-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 15-OCT-2014 the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # J003806, expiration date 03-JUL-2014), subcutaneous. Dose supported. No adverse experience reported. Additional information has been requested.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 12-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I began to hemorrhage severely and lost 6 pints of blood. This was 3 days after a colonoscopy where two polyps were removed. There was no bleeding after this, it started three days later after I had received the vaccine  I also was severely short of breath for two weeks afterwards
Pt returned to clinic on 10/9/09 complaining of runny nose and cough for three days and was diagnosed with nasal congestion and
The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain became severe by day 3. Pain spread to my right breast, neck, back, and right scapular area. I have had numbness in my fingers on right side. Today is 16 days. The pain increased every day for about 10 days. Decreases slightly and is now holding.  I'm am in terrible pain. I didn't sleep for 6 days when the pain was at is peak and still can barely sleep. It's the worst pain of my life. It feels like my arm is in fire and in a meat grinder. My arm and neck pain worsens when I use my arm or change positions. I am also getting flushed heat feelings on my face intermittently.  Since this vaccine I have had allergic reactions to ibuprophen and prednisone which sent me to the ER. Two medications I have received before with no problem. I also felt I was reacting to gargling with listerine which I have used before without issue.  I eat eggs regularly and got a small sensation of throat swelling with that too and have not eaten them again. My doctor is having trouble treating me since I am now having so many allergy symptoms to different things. I have been advised by my doctor not to continue with this vaccine or any vaccine in the future. I am still in terrible pain that is limiting me from participating i. my normal life activities.  I did not develop any rashes or obvious swelling at the injection site. Twenty minutes after receiving the shot I did get a bit flush feeling and some redness in my face and my ears felt hot and then cold. That resolved within about 45 minutes.
pt recv vax 1NOV97 & on 4NOV97 pt devel gen rash all over body;
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Patient reports hives on trunk & arms, which appeared within 15 minutes of taking first dose. Pt. reported this to provider on 2-25-13.
Patient accidentally given only the diluent portion of vaccine and was not given the powdered portion of the vaccine. No adverse reactions occurred.
pain on the injection site; This is a spontaneous report from a Pfizer-sponsored program via a non-contactable female Consumer (patient). A female patient of an unspecified age receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown.) via an unspecified route of administration on 23Jan2021 at SINGLE DOSE (first dose) for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications.  Patient was asking if it is okay to take ALEVE PM because there was pain on the injection site after she got the 1st vaccine during the morning on an unspecified date. Outcome of the event pain on the injection site was unknown.  No follow up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Red band around arm in area of administration about 2 inches in height, and 4 or 5 inches in length. Patient presented to physician where they were prescribed a steroid cream, and cephalexin oral antibiotic.
no additional AE; ROTATEQ  was administered after temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 14-AUG-2023 and 28-AUG-2023, a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1968393, expiration date: 24-MAY-2024) underwent temperature excursions of 8.9 degree Celsius for a time frame of 12 hours 20 minutes and 9.4 degree Celsius for a time frame of 8 hours 20 minutes, respectively. There was no previous temperature excursion. On 20-SEP-2023, the patient was administered the improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (1 dose; strength was not provided) orally for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC).
rashes like small red dots; itching; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 after 72 hours at 18:00, the patient had started noticing rashes like small red dots all over body especially from backside and front side of the body. They are kind of itching but not painful. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event rashes like small red dots and itching was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
MILD ITCHING: OVERALL BODY ITCHING MANIFESTED APPRX. 4 HOURS AFTER INJECTION ESPECIALLY AT FEET, EYES, HANDS AND ARMS.  NO RASH.  PATIENT TOOK DIPHENHYDRAMINE FOR ITCHING.  ITCHING LASTED APPRX. 24 HOURS. AUDITORY SENSITIVITY:  MINOR SOUNDS SEEMED AMPLIFIED. TO THE POINT OF IRRITATION  TINNITUS: SEVERE TINNITUS 4 TO 10 HOURS AFTER VACCINATION.   HAD SOMEWHAT DISAPPEARED BY 8 AM FOLLOWING DAY.  PATIENT STILL HAS MINOR TINNITUS.   MUSCLE AND JOINT STIFFNESS:  MUSCLE AND JOINT STIFFNESS MANIFESTED APPRX. 2 DAYS AFTER INJECTION AND LASTED FOR APPRX. 5 DAYS TOTAL.   PATIENT HAD NO INJECTION SITE REDNESS OR SWELLING.   PATIENT DID NOT SEEK MEDICAL TREATMENT FOR SYMPTOMS.
PATIENT RECEIVED 4TH DOSE OF DTAP ON MARCH 2, 2022 AND MOTHER HAS NOTICED RASHES/HIVES AT INJECTION SITE ON MARCH 4, 2022.
lips started to feel like it was stretching; mouth was watering; she felt as if her tongue did not want to sit in her mouth; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL DISCOMFORT (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "lips started to feel like it was stretching"; SALIVARY HYPERSECRETION (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "mouth was watering"; PARAESTHESIA ORAL (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "she felt as if her tongue did not want to sit in her mouth".  Additional information: Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday. While she was driving home, her lips started to feel like it was stretching, but when she checked, it was not swollen. She said her mouth was watering, and she felt as if her tongue did not want to sit in her mouth. Consumer said it eventually went away after 2 hours so she never sought medical attention. She was querying if she should still receive the second dose. She also wanted to know what are considered as mild reactions to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received PNEUMOVAX 23 on Monday, October 9 in the am; wife called on the afternoon of October 10 stating her husband was not able to leave his bed; that the pain in his arm was excruciating even when taking both aspirin/ibuprofen; No body aches or pains; only pain at the injection site.
Temp 105, leg pain, swollen thigh (left) redness: Treatment: TYLENOL, MOTRIN alternating, observation.
Within the next 24 hours after my entire left bicep couldnt move and was in severe pain.  My skin was warm to the touch, body aches and pain and sniffles, lots of congestion and complete fatigue and severe muscle aches. I had a slight headache also but in the middle of the night 2/3 to 2/4 I woke up drenched from sweat and had to redress because my clothes were soaked.  On 2/4 I had to have the air on because I was so hot but never developed a fever.  On 2/5 I was still fatigue and still couldnt do much.  2/6 I still had arm soreness but felt better overall and by 2/7 all symptoms had subsided.
upon arising pain was noticeable in rt arm;in the afternoon was a sudden onset of anterior chest heaviness radiating to upper back;also sudden onset of numbness in rt hand which progressed up to elbow;severe weakness -unable to write;
About a month ago, 03/04/2022, late in the day, 11:30 pm, I began to experience shortness of breath, chest pains, and right now I cannot bend my right arm all the way straight.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse (R.N.)) refers to an unknown number of patients of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of GARDASIL (dose, route, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursions, have been administered to an unknown number of patients. No adverse effect reported. This is one of several reports from the same reporter source. Additional information has been requested.
RECEIVED PFIZER VACCINE AFTER BEING FULLY VACCINATED WITH JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 203 pounds, and height was not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: Patient has no known drug allergies, healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 23-AUG-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination.  On 16-AUG-2021, the patient experienced received Pfizer vaccine after being fully vaccinated with Janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received Pfizer vaccine after being fully vaccinated with Janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210909424 and 20210909555.