chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second dose, the injection site and down the injection site was swollen. Like four or five inches in length and three inches across. The whole thing was swollen. It was warm to the touch. It did not itch. It looked like hickeys on my arm. There was no sign of infection, which is why I did not call the doctor. In a day or two it was better. After the third dose on 10/22/2021 (048F21A), like 12-15 hours later, about two inches below the injection site, I developed a very hard and dark red, three inches by three inches squared, that had a very fine edge. It was a solid maroon color. Very hot to the touch. It itched very much. I was worried it was cellulitis. The doctor said cellulitis happens at the injection site, and my reaction was below. It expanded a little bit to the back. You could fit your whole hand. The heat was so significant. I could feel the heat through a sweatshirt. They gave me ibuprofen and ice pack and wait to see what happens. I had to take a picture of it every day to see if it got worse or better. It was moderate by Saturday. Sunday It was significant. Monday was horrible, which is when I decided to see the doctor. By Thursday it was a little bit better. By now it is almost gone. The doctor said he has never seen anything like this before. Also, I had been sick two weeks prior to the booster. I had a fever 101.4. I got tested for COVID-19 and my PCR Test was negative. It was like a typical cold, which lasted for 3-4 days. I also received the Flu vaccine on 09/28/2021.
Patient given vaccine out of a vial given 24 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine out of a vial given 24 hours after puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine out of a vial given 24 hours after puncture). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine out of a vial given 24 hours after puncture) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    This case was linked to US-MODERNATX, INC.-MOD-2021-132785 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132785:Crosslink
Patient presented to CLINIC today with c/o of red rash. She showed me her primary area location of rash located around her pubic and pelvic area. Patient stated that the rash was on her back and other parts of her body, but did not show me those areas. Patient states that rash started 2 days after 2nd Moderna vaccination. Her 2nd Moderna vaccination was on 9/24/21 and rash appeared about 2 days after (9/26/21). She has not tried taking anything for relief. Today would be day 7 post-injection, and patient states symptoms have improved, but are still prominent around pubic and pelvic region. Called Doctor's office to relay information as patient is currently receiving radiation therapy. Advice nurse states that rash seems less likely from radiation as this would usually be localized to the breast area, and it's full body. I am filling out a report, and have called the patient to update.      I advised her to seek medical attention today with PCP, but she declined several times due to copay. I advised contacting her PCP and sending pictures, but she declined due to not knowing how to navigate well. We reviewed OTC medications that would be ok to take for pain or itching, and cool compresses. Advised monitoring the area for improvement. If rash worsens, patient verbally agreed to seek medical attention.
HAIR LOSS; MEMORY AFFECTED; BODY WEAKNESS; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hair loss, memory affected, and body weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hair loss, memory affected and body weakness was not reported. This report was non-serious.
This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (pain) and PERIPHERAL SWELLING (Swelling under the arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain) and PERIPHERAL SWELLING (Swelling under the arm). At the time of the report, VACCINATION SITE PAIN (pain) and PERIPHERAL SWELLING (Swelling under the arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Reporter did not allow further contact.
Patient got vaccine on 9-9-10 & then came into pharmacy 9-11-10 & her left arm was red & swollen from elbow up to shoulder she said it looked better than the day before - was told to take BENADRYL & go to MD if it worsen.
pt recvd fever 102 w/in 48hrs of shot;loose frequent stool, crying constantly
no additional adverse experience; VAQTA vaccine which underwent a supported temperature excursion; This spontaneous report was received from a healthcare worker and refers to a 10-year-old female patient. The patient's concomitant medications included unspecified influenza and polio vaccine. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies was provided.  On 07-OCT-2021, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), intramuscularly to the right deltoid, lot # T037329 , expiration date 30-APR-2022 for prophylaxis (exact dose, route of administration were not reported) by a nurse practitioner in the clinic.  Administered dose of vaccine has been stored in the temperature of 16.5 degrees Celsius for 2 hours. There were no previous temperature excursions reported. It was unknown if Digital Data Logger was involved. No adverse events were reported.   Additional information was not expected.
MISSED SECOND DOSE OF VIVOTIF; This spontaneous case report was received from a nurse (PVX2019-115) on 14-Jan-2019. The report describes a male consumer who "missed second dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003207 and expiry date: Feb 2019) for a typhoid fever prophylaxis.   It was reported that the consumer took his first on Friday and was supposed to take his next dose on Sunday (yesterday). However, his refrigerator failed and Vivotif went out of range for 6 hours. He did not take the dose on Sunday, thus missing the second dose.  The action taken with Vivotif with respect to the event "missed second dose of Vivotif" was not applicable.  The clinical outcome of the event "missed second dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed second dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed second dose of Vivotif" was considered as not applicable.
Information has been received from a pharmacist concerning a pt who was vaccinated with 3 doses of Hep-B vaccine and subsequently, the pt had a positive hepatitis B surface antigen test. The pt sought unspecified medical treatment. Additional information has been requested.
patient had swelling on the arm, which caused a lot of pain. patient went into the md office regarding this.
Patient complained up injection site pain, neck pain and unable turn head to left, back pain, Nausea, headache, fatigue
Experienced abnormal uterine bleeding for the four months following the booster shot. Periods were longer than normal, there was an increase in cramping and clotting, and experienced breakthrough bleeding. Ended in bleeding for a month straight, with extremely heavy bleeding at one point. Took Provera 2x/day for 5 days to stop bleeding; slowed bleeding while taking and then started what seemed like a regular period after stopping. All of the excess bleeding caused anemia that disrupted normal life: dizziness, lightheadedness, headache, extreme fatigue. Taking iron supplements to treat.
Patient fainted, lost consciousness for a minute, was rigid when she opened her eyes and her hands and feet were tingling.  Took her about 10 minutes to get normal feeling back in her hands and feet.  EMS was activated and they monitored her for about 30 minutes.  She was allowed to go home with her husband.  She is pregnant, but due date is unknown.
Expired Vaccine was adminstered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine was adminstered) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine was adminstered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine was adminstered) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Patient received 2nd booster dose   No treatment medications was provided by the reporter.
Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated SC with a 0.5ml dose of MMR II/Varicella. Shortly after vaccination, the patient developed several small red bumps near the injection site. No other symptoms were noted. Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been requested.
PATIENT REPORTS "HOT FLASH" SYMPTOMS (SWEATING, FLUSHING) BEGINNING IMMEDIATELY AFTER INJECTIONS THAT LASTS APPROXIMATELY 2 HOURS.  PATIENT HAS EXPERIENCED THIS REACTION AFTER EACH OF HER 4 COVID VACCINATIONS (ALL PFIZER)
watering eyes & nose; 3rd day coughing up green mucos; congestion & cold for 1 1/2 wk; aching legs & ankles, sore throat;
Five hours 5:30 pm after vaccination patient complained of being lightheaded, became clammy with a cold sweat and skin was cold and clammy to touch. He was pale, BP 90/66. Last night he had blurred vision. He has had blurred vision at times prior to vaccination. So blurred vision may be related to a medication he takes routinely. Pt laid down at 6 pm for about 2 1/2 to 3 hours and then felt better. After 9 pm pt had blurred vision when viewing computer screen. He is doing fine today. Treatment: rest, cold pack to back of neck, lying down, some nourishment.
LUE and LLE intermittent numbness, difficulty focusing L eye, numbness L half of face, lumps in muscles, pain/tingling R forehead, diffuse muscle pain and joint pain.
unexpected fall; irregular EKG; black floaters in eye; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, sngle for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "unexpected fall"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "irregular EKG"; VITREOUS FLOATERS (non-serious), outcome "recovered", described as "black floaters in eye". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that the reporter states he had the Covid vaccine the 1st and 2nd shot. The reporter said that there were 3 event that happened that might be related to it, first was an unexpected fall, and irregular EKG, and black floater in the eye. Black Floater is fine now. Physician told him that he should not have the booster. He is now fine. Clarified that this all happened after the second dose.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
patient started to experience lowpressure again; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (patient started to experience lowpressure again) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042j21a, 032m20a and 011m20a) for COVID-19 prophylaxis.     The patient's past medical history included Hypertension and Dialysis (Patient has been in dialysis for 7 years) since an unknown date. Concurrent medical conditions included Latex allergy, Allergy to antibiotic (contrast cepicillin) and Drug allergy (same family antibiotics ecogen drug to produce red blood cells).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (patient started to experience lowpressure again). At the time of the report, HYPOTENSION (patient started to experience lowpressure again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 100/60 100/60.         Concomitant medications were not reported.  Patient was allergic to teghade.  The patient had reported after vaccination with second dose, patient had low blood pressure - 100/60 and was not able to rise it and lasted for 6 months when it resolved. Patient stopped regular medication for high blood pressure, patient used to have with 2 medications ad blood pressure used to be 140/90. After vaccination with the 1st booster dose patient started to experience lowpressure again.  Patient had scheduled a transplant after receiving the vaccine for a condition that was diagnosed before receiving the vaccine .Patient had been in dialysis for 7 years and 2 days ago with general anesthesia the low pressure went so lowthat the transplant had to be canceled and their HCPs were not able to rise the patient's blood pressure. Patient never had low blood pressure before   Treatment information was not reported.
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient reported hives that did not itch
Severe red rash and hives on the face, neck, chest, back, feet and arms.  No itching with rash.  Gave Benadryl and Prednisone pills for several days, but these did not make the rash go away. Rash lasted 2 weeks and as of 1/31/13 is beginning to subside.  We called our family doctor when the rash began. He refused to see her because he did not administer the shot. He would not prescribe anything for the rash.
1/25/08 Pt reports since getting Tetanus shot in left arm, shoulder has been weak. On exam he has full ROM of the shoulder, but abduction is slightly decreased. No tenderness. Improving.
Upon initial injection (0940)pt reported some lightheadedness, pt sat for aprox 20 min and then stated feeling better.  She returned to her clinic to work and at 1030, reported return of s/s with increased severity.  She was brought back to vaccination area an evaluated by MD, given 50mg of po liquid Benadryl and then taken to ED via WC.  VS:  155/77, 105, 18, 96% on room air.
Patient reported feeling "dizzy", "heart racing", and "jitter" approximately 15 minutes after injection. No other reported symptoms. Vital signs stable; HR 78, BP 123/81, 100% oxygen on room air.  Patient noted to be extremely anxious, not able to sit still in chair. Remained in room with patient for 15 minutes, talked with patient, and provided her water. Patient monitored in room for 45 minutes, felt much better at this time and discharged at 2:02 pm.  States she did not take her lorazepam today.
This information was received from a consumer concerning his 13 month old son who was vaccinated with a dose of MMRII, IM, on an unspecified date. On 9/7/01, the child's father alleged that the following events were associated with the use of ibuprofen (Children's Motrin). On an unspecified date, 4 minutes after the ibuprofen was given for fever of 104.3F, his son sat up in his crib, began staring blankly and his eyes rolled back and to the right. The father reported that his son was not convulsing and that he rushed the child to the closest medical facility, while reporting the events to the physician, the child remained in a trance, lifeless and developed cyanosis of the lips, genitals and extremities. The child was immediately treated with oxygen, turned pink and began crying. The father reported that no additional treatment was given and the child was discharged after being stabilized, once the fever improved. According to the parent's report, the physician attributed the event (75%) to a ibuprofen allergy and (25%) to the fever. The following day, the child was taken to the doctor, who reportedly believed that the event was a delayed reaction to vaccination with MMRII, received 3 weeks prior, since there was no increase in his WBC. The child was also taken to a neurologist who performed an EEG and could not attribute the event to ibuprofen or MMRII. The father reported that the neurologist classified the event as a febrile seizure. Subsequently, the pt recovered. Febrile seizure and cyanosis were considered to be "Other Important Medical Events". Additional information is not expected.
Patient with history of seizures. Had vaccination in the AM. That afternoon with seizures. Seems to be medication complaint per son. Post ictal had resolved at time of evaluation.
Pt reported nausea, sweating, dizziness, light headed ness. I counseled to sit on chair, clench fists, and bend forward with  head between legs. She drank water. She felt better after a few minutes. I checked blood pressure and it was 126/80  and 103 heart rate.
Dx @ eye doctor with papilledema, sent to ER for spinal tap. Went back to ER and found to have blood clots brain. New seeing Neurologist. Pending MRI of brain. Eye exam w/physicians 6/19 or 6/21 (not sure). They said she had swollen optic nerve; which indicated something pressing against nerve; and MRI confirmed one @ facility
Nausea, diarrhea, headache, rash on chest, shortness of breath, loss of color in face, dizziness, light-headed, extreme fatigue (could not drive home from site), elevated blood pressure
patient states the night after the vaccine he had a nosebleed and it stopped on its own.  Then he complained of a sore, raw tongue and that it burned when he drinks juice and taste bad. Patient states he had not been exposed to a positive COVID case that he was aware of.
Couldn't move; wiped out; got sick the next day; simultaneous diarrhea and vomiting/vomiting/diarrhea; vomiting/simultaneous diarrhea and vomiting; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Couldn't move), ILLNESS (got sick the next day), DIARRHOEA (simultaneous diarrhea and vomiting/vomiting/diarrhea), VOMITING (vomiting/simultaneous diarrhea and vomiting) and FATIGUE (wiped out) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 024M20A, 047A21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Kidney disorder. Concomitant products included MULTIVITAMIN [VITAMINS NOS], KRILL OIL and PROBIOTICS NOS for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ILLNESS (got sick the next day), DIARRHOEA (simultaneous diarrhea and vomiting/vomiting/diarrhea) and VOMITING (vomiting/simultaneous diarrhea and vomiting). On an unknown date, the patient experienced MOBILITY DECREASED (Couldn't move) and FATIGUE (wiped out). On 14-Feb-2021, DIARRHOEA (simultaneous diarrhea and vomiting/vomiting/diarrhea) and VOMITING (vomiting/simultaneous diarrhea and vomiting) had resolved. At the time of the report, MOBILITY DECREASED (Couldn't move), ILLNESS (got sick the next day) and FATIGUE (wiped out) outcome was unknown.            Patient's concomitant medication included CoQ10. No treatment information were provided.
On day 7, my left arm began itching intensely at the site of injection. The next day two dime-sized red  spots appeared that felt like knots. The redness expanded to the size of an egg over the next few days then began to recede. The edge of the redness had a line similar to Ouchterlony. Today, day 14 after vaccination, there are still the two dime-sized spots that are  pink but visible from several feet. There was no soreness associated with this reaction and the itching was gone after two or three days.
Breakthrough case admission after 4 vaccines moderna 2/12/21 lot# 015M20A;  Moderna 3/2/21 lOt# 002B21A;  Moderna 11/8/21 lot# 034F21A;  Moderna 4/5/22 lot# 048L21A
Immediately after injection, there was a feeling of being warm and lightheaded within a minute after sitting in the waiting area. As I have had a history of low blood pressure and feeling lightheaded and occasionally fainting after injections during adolescence, I monitored my symptoms to see if they were progressing. However, those symptoms seemed to dissipate after 5 minutes. Then arm soreness started within 10 minutes after injection and worsened over the course of the day. As pain began, arm was rotated and moved around which seemed beneficial in improving the discomfort. As the level of arm soreness seemed moderate and tolerable, there was no additional treatment besides moving and stretching the arm. The arm soreness was  However, when trying to go to sleep more than 12 hours after injection, the arm pain was problematic enough to prevent sleep. I then shifted my weight onto the arm that received the injection which seemed to alleviate the soreness and was then able to fall asleep. The arm soreness was still there the next day but less noticeable and more tolerable.