chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I believe all or some of the second dose leaked out of the injection site, which was about 2 inches higher up on my arm than the first injection (very close to the shoulder joint).  After the injection, the nurse wiped the injection site 2 or 3 times with gauze, which felt very cold.  She then disposed of the gauze in a medical waste container.  She then applied a band aid.  There was no mention of any leakage of the vaccine.  I didn't think too much of it until I described it o my wife, who is an RN and a Covid vaccinator.  She believes there was leakage.  After the first dose, I had fairly bad fatigue and sore arm.  After the second dose, just a very small amount of soreness, but no other side effects.  Should I get another dose?
Felt fine as I got the shot, after 3-4 minutes I felt light headed, and passed out.  After a few minutes (at most 5) woke up and immediately felt better.  I believe this was due to the needle not the shot as I have felt light headed in the past almost any time I have gotten a shot.  This was the first time I passed out though (usually I am already laying down, or able to without getting up.   I was in a chair and could not).
Began with inconsolable crying on 9/14/04 and continued for 48 hours. Had trouble sleeping. Was treated with Tylenol.
This spontaneous report was received from a pharmacist via a company representative and refers to a 72-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with one shot of  PNEUMOVAX 23 lot# N022703 and expiration date 27-FEB-2019 (route of administration was not reported). On an unknown date, after receiving PNEUMOVAX 23, the patient experienced swelling between the shoulder and arm. On an unknown date, when the swelling went down, the area began to itch. The patient did not seek medical attention. The outcome of swelling between the shoulder and arm was recovered. The outcome of itching was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
About 12 hours after immunization he began having a small area of redness & swelling on left upper arm. He was taking doxycycline for hand cellulitis went to the ER on 4/8 and received vancomycin because the redness was worsening. Went home on Doxycycline. Went to doctor on 4/9. Went to ED on 4/10 because redness and swelling was getting worse in past 12-24 hours. Also noted warmth and tenderness.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, duration and route were unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient experienced blisters around the injection site after having been given ZOSTAVAX. The patient had sought unspecified medical attention. No treatment information was reported. At the time of the report, the outcome was unknown. This is one of the several reports received from same reporter. Additional information has been requested.
Patient was admitted toER on 11/12/22 at high elevation.  Patient blood oxygen was under 70%.  Patient was admitted to hospital and taken off of Plaxlovid and started on Remdesiver 5 day treatment.  Patient was recovering but on 12/17/22 complained of distended abdominal pain and was bleeding in her abdomen.  Emergency surgery was performed to stop the bleeding.  Patient was in ICU for 5 days then moved to a floor bed.  Discharged 1 day later to return home.
the size of the shot of numbness from my face down; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (the size of the shot of numbness from my face down) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (the size of the shot of numbness from my face down). At the time of the report, HYPOAESTHESIA (the size of the shot of numbness from my face down) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Pt complained of arm pain waking him up at night where hepatitis B vaccine given. Unable to have good strength in arm hours after administration.
Initial information received on 25-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 72 years old female patient who experienced lost hearing in both ears and flu, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Sep-2018, the patient received a dose of suspect 0.5 mL INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in right arm. On 17-Oct-2018, the, the patient developed a serious event lost hearing in both ears (deafness bilateral), one month six days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On 15-Oct-2018, the patient developed a non-serious flu (influenza like illness) with symptoms cough, temperature was 102 degrees (pyrexia) and chills, one month four days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient had a cough up until yesterday (recovered), fever and chills, 2 days after she had gotten the flu she noticed she lost her hearing. She lost hearing in both ears but the left ear was starting to get better. She still could not hear out of her right ear and described that the sound she hears in her right ear a silent sound. Relevant test included body temperature 102 degree Celsius. Final diagnosis was flu and lost hearing in both ears. It was not reported if the patient received a corrective treatment. On an unknown date, the patient was recovered from cough. The outcome of the other events was not reported. List of documents held by sender: none.; Sender's Comments: This case involves a 72 years old patient who presented with lost hearing in both ears and flu with fever, chills, cough post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccines cannot be assessed.
Broke out in a rash mainly on chest area. I broke out two days after getting the vaccine. The rash is continuing after two weeks.
Info has been received concerning a 56-day-old male child with no known allergies and no past medical history who on 09/17/2002 at 3:30 PM was vaccinated in the right thigh with a 1st  dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast ) (Lot #643661/0723M). There was no concomitant medication. There was no illness at time of vaccination. On 09/17/2002 at 3:30 PM the pt developed injection site swelling and redness. It was reported that a "knot" still remains and the pt is showing tenderness to the area by guarding it. The reporter expressed a concern regarding the lot #643661/0723M. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also indicated that other patients developed adverse events (WAES #0211USA02414 and WAES #0211USA02173). No further info is expected.
Tested positive for COVID-19 after vaccination. The patient was sent to the ED by his PMD for left sided facial, neck, shoulder, groin tingling for 6 months, and gait instability for 1 month (he was seen in the office since 4/2019 for these symptoms, but worsened with dizziness in the last 6 months). CT myelogram of cervical spine 1/2020 found multilevel cervical spondylosis greatest C4-6 with moderate to severe central canal stenosis at C5-6 which had progressed with increased flattening of ventral cord. Patient was also  found to have COVID 19 requiring 4L of oxygen via nasal cannula. He has since been weaned to 2L oxygen. He is on day 3 of dexamethasone 6 mg PO daily.
His legs but mostly his left leg, have been swollen/ Legs were going to puff; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (His legs but mostly his left leg, have been swollen/ Legs were going to puff) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (His legs but mostly his left leg, have been swollen/ Legs were going to puff). At the time of the report, PERIPHERAL SWELLING (His legs but mostly his left leg, have been swollen/ Legs were going to puff) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
Vertigo which got worse after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo which got worse after the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VERTIGO (Vertigo which got worse after the shot). At the time of the report, VERTIGO (Vertigo which got worse after the shot) outcome was unknown.            No concomitant medications were reported No treatment medications were  reported   This case was linked to MOD-2021-331252 (Patient Link).
On May 20th I felt off, persistent discomfort lower belly area, on AM Friday May 21 a significant increase in the discomfort, later that morning at hospital testing was done and I had Appendicitis, an emergency appendectomy was performed in the afternoon of May 21, 2021
FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and 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: Unk) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The batch number was not reported and has been requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
I didn't have this reaction with the first two doses, just a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 0.3 ml single and (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I didn't had this reaction with the first two doses, just a little tired".  Additional information: The reporter stated Something happened, the patient didn't have this reaction with the first two doses, just a little tired but nothing happened to her eye.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received Varivax - 6-14-07 - Began with "Chicken Pox" Varicella lesions 6-20-07
face is red flushed; Today (16 Jan 2021) her arm is again red, itchy; Today (16 Jan 2021) her arm is again red, itchy; area of injection site is 4 inch long and 2 inch wide; injection site swelling; arm reaction like redness and swelling but it resolve.; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face is red flushed), INJECTION SITE PRURITUS (Today (16 Jan 2021) her arm is again red, itchy), INJECTION SITE ERYTHEMA (arm reaction like redness and swelling but it resolve.), INJECTION SITE ERYTHEMA (Today (16 Jan 2021) her arm is again red, itchy) and INJECTION SITE SWELLING (area of injection site is 4 inch long and 2 inch wide) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (arm reaction like redness and swelling but it resolve.) and INJECTION SITE SWELLING (injection site swelling). On 16-Jan-2021, the patient experienced FLUSHING (face is red flushed), INJECTION SITE PRURITUS (Today (16 Jan 2021) her arm is again red, itchy), INJECTION SITE ERYTHEMA (Today (16 Jan 2021) her arm is again red, itchy) and INJECTION SITE SWELLING (area of injection site is 4 inch long and 2 inch wide). In January 2021, INJECTION SITE SWELLING (injection site swelling) had resolved. At the time of the report, FLUSHING (face is red flushed), INJECTION SITE PRURITUS (Today (16 Jan 2021) her arm is again red, itchy), INJECTION SITE ERYTHEMA (Today (16 Jan 2021) her arm is again red, itchy) and INJECTION SITE SWELLING (area of injection site is 4 inch long and 2 inch wide) outcome was unknown and INJECTION SITE ERYTHEMA (arm reaction like redness and swelling but it resolve.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Seasonal medical condition of headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Seasonal medical condition of headache". Therapeutic measures were taken as a result of headache.  Additional information: Caller, (name), had their 1st shot 25Mar with her husband named (name withheld), then had their 2nd shot yesterday 15Apr. They have a seasonal medical condition of headache, and they were told from the clinic to not take any pain reliever, example aspirin and tylenol. They usually take Ibuprofen for their seasonal headache. Asked how long for them before they can take medicine for their headache. Refused to transfer to department due to a long queue. She will just ask pharmacists. Submitted and created manual AE form. Provided contact number.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Loss of smell; Headache; I got tested and being positive with covid19; My symptom was sore throat; Loss of taste; No strength; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021. The most recent information was received on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got tested and being positive with covid19), OROPHARYNGEAL PAIN (My symptom was sore throat), AGEUSIA (Loss of taste), ASTHENIA (No strength) and ANOSMIA (Loss of smell) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sore throat from 17-Jul-2021 to 21-Jul-2021.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced COVID-19 (I got tested and being positive with covid19), OROPHARYNGEAL PAIN (My symptom was sore throat), AGEUSIA (Loss of taste), ASTHENIA (No strength) and HEADACHE (Headache). On an unknown date, the patient experienced ANOSMIA (Loss of smell). The patient was treated with AMOXICILLIN (oral) for Sore throat, at a dose of 875 mg twice a day and PREDNISOLONE (oral) for Sore throat, at a dose of 15 ml once a day. At the time of the report, COVID-19 (I got tested and being positive with covid19), OROPHARYNGEAL PAIN (My symptom was sore throat) and HEADACHE (Headache) outcome was unknown and AGEUSIA (Loss of taste), ASTHENIA (No strength) and ANOSMIA (Loss of smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were reported.   This case was linked to MOD-2021-261824 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information received on 29-JUL-2021 contains significant information .Patient  demographics updated. Patient history (sore throat) added. Treatment medications Added. Event (loss of smell) added.
turned blue (stopped breathing) poss febrile sz; 911 called, stabilized via CPR per EMT; hospitalized;
pt recvd vax 11NOV92 & the same evening devel redness, swelling, tenderness & stiffness w/limitation of movement of arm; arm was also hot to touch; pt also devel difficulty breathing; pt given Vistaril for bronchospasm; poss allerg react;
My arm is still sore; Stomach cramps/very uncomfortable pain and felt like a menstrual cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is still sore) and ABDOMINAL PAIN UPPER (Stomach cramps/very uncomfortable pain and felt like a menstrual cramps) in a 73-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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm is still sore) and ABDOMINAL PAIN UPPER (Stomach cramps/very uncomfortable pain and felt like a menstrual cramps). At the time of the report, PAIN IN EXTREMITY (My arm is still sore) and ABDOMINAL PAIN UPPER (Stomach cramps/very uncomfortable pain and felt like a menstrual cramps) had resolved. Not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-032185 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up received on 16 JUL 2021 and event outcome updated.; Sender's Comments:  MOD-2021-032185:
I started having joint/muscle pain since about one day after the vaccine.  I have had worsening joint/muscle pain since that time.  I took a break from my anastrazole in January 2022 and again in August/September 2022 with no difference in symptoms.  I went to a rheumatologist and was diagnosed with rheumatoid arthritis without rheumatoid factor, myalgias, and arthralgias in January 2023.  I also cannot concentrate enough to read a book any more.  I also have severe tinnitus that sometimes wakes me in the middle of the night and shortness of breath when I am not doing anything.
chronic spontaneous hives all over body, including face. No allergies found in skin test. Been taking antihistamines everyday but body does not respond. Steroids were given in emergency room, body did not respond.
patient experienced swelling and redness around the injection site, similar to "Covid Arm" symptoms and reaction
Same rash as 2 previous events: Rash started in the face and traveled to neck, torso, and legs. Itching. This time the rash was accompanied by significant facial swelling.
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with RECOMBIVAX HB (the name and manufacturer was unspecified). After receiving the vaccination, the patient was very colicky, could not tolerate milk, had a lot of bowel movements and could only sleep for a couple of hours. The outcome was unknown. It was not specified if the patient sought medical attention or not. The mother also reported that on an unspecified date, after the patient received diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), he spiked a 104 degree fever. The mother also reported that the patient was diagnosed with autism after received MMR II (WAES # 0903USA05205). This is one of several reports received from the same source. Additional information has been requested.
I work at an assisted living Facility. My employer set up a vax  clinic for us to receive the 2 shot Moderna vax.   This was an outside company that actually came to us an administered the shots.  It was not administered by  an employee  at my workplace.    The pain was almost immediate post shot.   It is now January  2022.    I  have limited range of motion is the arm.  It is particularly bad at night as I am unable to sleep on that side without extreme pain.   I did get the second shot on 2/17/2021 and asked that it be injected in my LEFT ARM as the right one still hurts.   No problem with that one.