chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after vaccine, had mild aches and chills. Developed tinnitus the day after vaccine and it is constant ringing in my ears.  It is more than six week later and still have constant ringing in my ears. My understanding is there is no cure for tinnitus.
put me in bed, make me feel miserable; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient reported that he/she received dose of Shingles vaccine 4 days ago of the reporting time and felt miserable. The patient stated that vaccine kept him/her in bed. The patient thought it was COVID but later got the COVID test and patient was COVID-negative. The patient back to his/her life till the time reporting he/she waiting for second dose of Shingles vaccine. The follow-up would not possible as no contact details were available.
I gave the patient several drops of ROTATEQ and he vomited within several seconds of swallowing. I repeated this 2 more times with the same results.
Redness, itchiness, hot, hard. Was given Benadryl and hardness went down.
Patient was found down at home by family. She was unresponsive. Brought into ER with hypertension. Immediately put on Cardene GTT and intubated. HCT showing an intraparenchymal hemorrhage and an Intraventricular Hemorrhage.  Patient placed on 3% saline solution. Repeat HCT in early AM showed worsening IPH. Repeat one 6 hours later showed stability.
Upper arm pain; Neck and back pain; Neck and back pain/Shoulder pain; General joint pain; Administration date 08Oct2021 at 13:45, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 08Oct2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included spondyloarthropathy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and adalimumab (MANUFACTURER UNKNOWN); both taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 41-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 15:45, the patient had "administration date 08Oct2021 at 15:45, dose number=3". On 09Oc2021, the patient experienced upper arm/shoulder pain, neck and back pain and general joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events upper arm/shoulder pain, neck, back pain and general joint pain and included self treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upper arm/shoulder pain, neck and back pain, and general joint pain was not recovered at the time of this report. The clinical outcome of the event "administration date 08Oct2021 at 15:45, dose number=3" was unknown at the time of this report.
GENERAL ACHING; BAD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 56 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085031, and batch number: 1085031 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 12:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced general aching. On 03-APR-2021, the subject experienced bad headache. On 03-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from bad headache, and general aching. This report was non-serious.
Pt experienced burning sensation inside mouth, itchy tongue, and nausea.  Pt has had similar reaction in the past when given macrobid, which pt is allergic to. Pt did eat 45 minutes before appt and has stated that they have type 1 diabetes.
Patient received vaccine approximately 11:05am, returned to clinic at 12:30 complaining of tongue feeling swollen and difficulty swallowing. Patient evaluated, no abnormal findings, instructed to take Benadryl and follow up with ER/CALL EMS for emergent worsening symptoms.
I had a bad cold and was very congested around June 6. My wife asked me to get tested for COVID-19. I went to the pharmacy on June 10 to have a PCR test run. On June 11th, I did a home test and it was positive. I called my primary care doctor who prescribed Paxlovid. I then received a text saying my PCR test was negative. I took another home test on June 12th and it also was positive. I started Paxlovid on the 11th and took it for 5 days. I also took an over the counter Mucinex with an expectorant. The symptoms have gotten less and less as days went on. I am not nearly as congested. I have been blowing my nose a lot.
I continue to have moderate to severe pain in my arm where I received the INFs (influenza split virus) shot.  It is painful to raise my arm.
I had very little side effects from the booster shot compared to the second covid vaccine I had received approximately 8 months prior. I just had a mild headache and mild ache at injection site vs. chills, headache, joint pain, body aches, severe pain at injection site.  3 weeks later, I was feeling under the weather, but would test negative when using an at home covid test kit. Then, my boyfriend, whom I live with, tested positive for covid and we did not isolate him nor avoid direct contact. I was feeling ill for over a week and tested every other day but continued to test negative. Finally, on Jan 9, 2022, I lost my sense of smell and taste and got a covid positive result
PATIENT REPORTED HAVING A "SWOLLEN" FOOT THAT LASTED FROM 9 TO 13 DAYS, AFTER RECEIVING THE FIRST COVID MODERNA SHOT.  SHE HAD A DOCTOR VISIT BUT THERE WERE NO INTERVENTIONS INITIATED BY HER DOCTOR.  THE SWELLING RESOLVED ON ITS OWN.
mild fever of ~100*F; general mild flu like symptoms; caused trouble sleeping; headache; tiredness; chills; nausea; joint pain (specifically in hips); body aches; This is a spontaneous report from a non-contactable consumer or other non hcp. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 11:45 (Age at vaccination26 Years old) (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ethinylestradiol, etynodiol diacetate (KELNOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 01:30 the patient experienced 13-14 hours post-vaccination chills, nausea, joint pain (specifically in hips), mild fever of ~100*F (fever came around 2:30 am, woke up at 6 am with no fever), body aches, general mild flu like symptoms which caused trouble sleeping; 24 hours post-vaccination: body aches, joint pain (mostly in hips), headache, tiredness. Side effects were only mild to moderate, nothing serious or severe. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on 10Feb2021 mild fever of ~100*F (fever came around 2:30 am, woke up at 6 am with no fever). Outcome of events was recovered on unspecified date of Feb2021.    No follow-up attempts are possible. No further information is expected.
Chronic hives. Sought treatment in May after it did not go away and became worse. Dr. prescribed 180mg Allegra and 10mg singulair. This seems to keep it under control. After 1 mo. hives came back after only stopping treatment for 1 day. Restarted treatment.
extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid heart beat; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6205, via an unspecified route of administration, administered in left arm on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic, penicillin allergies, allergies to sulfa drugs and bee stings. Concomitant medication included calcium. Historical vaccine included BNT162B2 on 11Feb2021 (lot number: EM9810) for COVID-19 immunization. On 04Mar2021, after 1 hour, the patient experienced shortness of breath and rapid heartbeat. At 12 hours, severe headache, fever (100 degrees) nausea, faintness, extreme fatigue 24 hours later, started to feel normal again 6 hours later. No treatment information was reported. The outcome of the events shortness of breath and rapid heartbeat was recovered on 04Mar2021, For events faintness, severe headache, fever (100 degrees), nausea and extreme fatigue was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. In February 2014, reported as 2 years ago, the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were not provided). The patient's concomitant medications were not reported. Approximately in 2014, after being vaccinated with ZOSTAVAX the patient experienced a rash down her right arm (rash). The patient seek medical attention and the pharmacist instructed the patient to go to an unspecified Emergency Department at that time, however it was not known if patient went. No product quality issue was involved. At the time of the report, the outcome of rash was unknown and the relatedness between rash and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
headache; temperature at 100.5 degree F; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Lot Number: EN6206) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated, "I had the vaccine on Saturday, and I had a bad reaction to it. I had a 100-degree temperature for twenty-four hours (on 07Mar2021) and headache. The patient underwent lab tests and procedures which included body temperature: 100-degree temperature fahrenheit on unspecified date and body temperature: 100.5 fahrenheit on 07Mar2021. The outcome of events was Unknown.  No follow-up attempts are possible. No further information is expected.
Received flu and pneumonia vaccine on 10/20/08.  C/O pain in injection site (LA) immediately.  Continued to be painful with radiation under arm to L breast area.  Vomiting on 10/21/08--reported to ER on 10/21/08.  Swelling, redness @ site.  Patient requested both given in L arm. Patient has signed release of record form to get hospital records for further medical information regarding this incident. 11/18/08 Reviewed hospital medical records of 10/21-10/24/2008. FINAL DX: cellulitis left shoulder; right shoulder pain secondary to fall at home; & acute gastroenteritis w/dehydration Records reveal patient experienced nausea, vomiting & weakness x 2 days.  Injection site edema, erythema, warmth & pain which extended into left anterior chest wall.
Delayed reaction 7 days post injection.  Red, warm, itchy large circle on upper right arm at injection site
No adverse event; Patient received the bivalent booster as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster as their first dose).    No concomitant medication information was provided. It was reported that patient received bivalent product for first dose instead of monovalent dose. No treatment medication were provided.
Expired vaccine given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: follow-up document contains no new information.
Pt faint and collapsed on the floor 2 minutes after taking the shot. It last for few seconds. He hit his head on the floor. He reconciled was back to normal within minutes. No ttt.
1. On day 6  after injection, I awoke to painful swelling on left clavicle and left side of neck (likely swelling of the lymph nodes). It is still persisting. Pain decreased, swelling has not.   2. On day 8 past the injection, I awoke to a large, red, swollen, itchy, and painful area of my left arm near the injection site ("covid arm")
Started with arm hurting at vaccination site, Later that evening got a bad headache.  Headache kept waking me during the night.  Next day 8:45am temperature 99.6 degrees.  At 1:00pm temperature was 100.4 degrees.  On the advise of the pharmacist took 1 Tylenol at 2:00pm.  Took another Tylenol at 8:00pm.  My temperature at 8:15am was 98.4 degrees.  The next day I felt very much better which kept improving during the day.
DEAD SHOULDER; SOME DROOLING IN FACE; This spontaneous report received from a patient via a company representative 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. No concomitant medications were reported. On an unspecified date, the patient experienced dead shoulder, and some drooling in face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dead shoulder and some drooling in face was not reported. This report was non-serious.
Extended length of time after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extended length of time after the 1st dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended length of time after the 1st dose). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Extended length of time after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, SARS-CoV-2 test: positive (Positive) positive. On 11-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. No treatment medication reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up updated on 21-JUN-2021: contain primary reporter details, patient demographic,  Lab report  updated for COVID-19 test
severe dizziness & very pale;the dizziness lasted about 1hr 5minutes;
Administration Error-Formulation and dosage; Peds vaccine given for 12 yr. old  Will verify that the correct dosage was administered to the patient. Nursing staff report that incorrect documentation may have occurred.
Inconsolable starting day after vaccine, lasting 2 days, ass. w/incred. GERD ("vomiting quite a bit"), no change in bowel habit.
Initial report was received from a healthcare professional on 18 September 2013. A 43-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, lot number C443 (corresponding Sanofi Pasteur Inc. lot number U4667AA) and an intramuscular injection in the left deltoid of FLUZONE, lot number UH896AB, on 05 September 2013. An immediate bump developed on the left deltoid and the area became hot to touch. On 12 September 2013, the bump popped and had yellow/greenish drainage. Several days later the bump became hard. The patient was seen by her primary care physician and clindamycin was prescribed. The patient was seen in the office on 18 September 2013 and symptoms have improved but have not yet resolved. The patient had no illness at the time of vaccination and allergies to ZITHROMAX, BACTRIM and doxycycline. Outcome was not recovered. Documents held by sender: None.
Nausea, lightheadedness, allowed to rest, feet up, cold compress on head. After 10 min c/o of headache, at 30 min hungry-eating snack. (At 11:00 Mom picked up to take home).
Patient was inadvertently given 1 ml of influenza vaccine instead of correct 0.5 ml dose.  Patient reported no adverse events.
Large area of swelling in right arm with extention to elbow and shoulder, are warm. Whitish color surrounding area of vaccine administration, clear fluid at site of injection. Began 1 day after injection, not improved after 24hours of benadryl, zyrtec,and cold compress. Added Augmentin after day 2 of reaction worsening
Relieve pain but not completely; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic drug effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included blister (From the sternum breast bone, across the right breasts, under the arm, around the back to the spine, and down the right arm to the fingertips and the worst area was the armpit). Concurrent medical conditions included pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unexpected therapeutic drug effect (Verbatim: Relieve pain but not completely). The outcome of the unexpected therapeutic drug effect was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient had big weepy blisters that hurt and itched at the same time the physician stated that it was not unusual for a patient to blister up twice, but when he/she had blistered up the third time the physician stated that he had never seen that happen. The patient blistered up fourth time then the physician stated that some was gonna have to rewrite all the medical books because that had never been reported. The patient reported that he/she still have some pain in that area. The patient received Shingles vaccine and it had helped him/her to relieve the pain a little but not completely. The patient reported that hopefully he/she will not get the blisters again, he/she trusting in to protect him/her from another flare up. Follow-up would not possible as no contact details were available. The patient stated that the shingles vaccine helped him/her to relieve pain, which led to unexpected therapeutic drug effect.
This spontaneous report was received from an 80 year old male consumer reporting on himself. On 29-APR-2015, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided). On 01-OCT-2015, the patient was diagnosed with the shingles on his left thigh and upper leg. On 03-OCT-2015, the patient was seen by his physician and treated with acyclovir ointment and valacyclovir hydrochloride 1 gram tablets. The outcome of the shingles is unknown. Aditional information has been requested.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 21-NOV-2016, the patient received an expired dose of PNEUMOVAX 23 (prefilled syringe, lot # K022886 with expiration date 09-JUN-2016; dose unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.