chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up was received on 27-APR-2021 and contact information was updated.
SEVERE VOMITING; DRY HEAVING; SWEATS; CHILLS; NAUSEA; FATIGUE; RED ARM; SWOLLEN ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced red arm. On APR-2021, the subject experienced swollen arm. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced severe vomiting. On 10-APR-2021, the subject experienced dry heaving. On 10-APR-2021, the subject experienced sweats.  On 10-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vomiting, dry heaving, sweats, and chills on 10-APR-2021, and nausea, and fatigue, and the outcome of red arm and swollen arm was not reported. This report was non-serious.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse was reporting that the patient received the first dose of GARDASIL (injection, strength, lot#, dose/frequency, route and duration were unspecified) on 27-JUL-2009 and the second dose (injection, strength, lot#, dose/frequency, route and duration were unspecified) on 13-MAY-2013. No adverse effect reported. The outcome was unknown. Additional information has been requested.
COUPLE OF DAYS AFTER RECEIVING VACCINE SHE STARTED EXPERIENCING SEVERE ARM PAIN SPREADING TO SHOULDER,NECK, COLLAR BONE & BACK. SHE TOOK IBUPROFEN , IBUPROFEN DIDN'T HELP HER THAT MUCH & SHE END GOING TO CLINIC ON 4/19/2021. THEY GAVE HER STEROID. SHE HAS FOLLOW UP WITH HER PCP ON 4/21/2021.
09/28/2014 c/o "BEING SICK". 10/02/2014 AT 7:00 am fell in BR. Unable to walk well even w/assistance. To ER by Ambulance. In ER, AA & O, moving all extremities. On the way to CT, she had a localized seizure involving BLE. Witnessed by myself and CT tech. Had CT< returned to ER. Had a longer T/C seizure beginning in BLE and then involving all parts of body. Head turned upward and to right. Eyes deviated upward and right but conjugate, Not responsive at this time. Lasted 1.45 minutes to 2 minutes. Given Ativan w/o change. No somulent again. Transferred to ICU. Later on during the same evening, she experienced a full T/C seizure lasting > 30 minutes. Given paralytics to get her intubated and started on Diprovan drip along with other meds. Continued with paralytics and was ventilated. She had a 24/7 EEG monitor placed which continued to show seizure wave patterns. When they let her up from her meds, she was now paralysed and comatose. Remained ventilated. After a family conference with Internal Medicine and Pulmonologist, it was decided to extubate her and allow her to die. Which she did after 45-60 minutes. These were her wishes, in her Durable Medical POA.
Patient received vaccine and then afterwards we learned that he already had a Moderna Bivalent booster on 9/22/22, so he did not need another dose. He didn't even remember getting the vaccine but it was written on his COVID card and present in the Registry. No adverse events reported as of right now.
I gave a pediatric/adolescent dose of Hep B rather than the adult ENGERIX Hep B.
hives; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   In SEP-2023, the patient received RSV vaccine and INFLUENZA VACCINE. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced hives (Verbatim: hives).The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to RSV vaccine.   It was unknown if the company considered the hives to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The patient got RSV or flu vaccine 3 weeks ago and still had hives. The patient never had them before. It was unknown if the reporter considered the hives to be related to Flu vaccine. The follow up would not possible as no contact details were available.
Had a rash all over it; Reaction to the vaccine; Red; Irritating; Itching; Painful; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events reaction to the vaccine/Vaccination site reaction, started at the injection site and expanded all over her arm, red/Injection site erythema, irritating/Injection site irritation, itching/Pruritus, painful/Pain in extremity, had a rash all over it/Rash.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) reaction to the vaccine, started at the injection site and expanded all over her arm, red, irritating, itching, painful, had a rash all over it.  Treatment details included Cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), reaction to the vaccine, started at the injection site and expanded all over her arm, red, irritating, itching, painful, had a rash all over it was unknown.
Within a minute after the injection, patient got up and was trying to check out with the receptionist when very suddenly felt lightheaded, dizzy, blurred vision, started to sweat uncontrollably and then proceeded to go to the rest room to vomit. At this time he was trying to ask if what he was feeling was from the shot, but was having trouble communicating because he was feeling so ill. The office tried to sit him down in a chair far away, but he had so much lethargy that they decided a room would be better for him to recover in.  Then one of the doctors informed patient's wife (myself) to come in because of a change in basal temperature. It seemed to us that both doctors were thinking this reaction was psychological in nature caused by fear or anxiety of getting the shot. After I joined my husband the doctor offered a cup of water and later a cup of Gatorade. The patient also sat on the patient table and brought his knees to his chest as recommended by Dr. During all of this time, he is sweaty very heavily with blurred vision.
Error occured when administering a dose of the vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered 28 mcg instead of the intended 10 mcg.  Patient/caregiver did not report any adverse events.
within 10 days I had severe breathing problems that lasted about 4 days, had test that revealed blood clots in my lungs about a week after
Went to bed with chills, body aches, sweating and headache. Woke up a few hours later with heart palpitations with 128 bmp that kept climbing, dizziness and shortness of breath.  Went to ER and was monitored for several hours. Had an EKG, temperature check and was given Tylenol.  Headache pain increased but heart rate started to come down enough to be discharged, heart rate was down to around 80 bmp.
PER PT ROUGHLY 5 DAYS AFTER RECEIVING 2ND DOSE OF MODERNA SHE DEVELOPED A PAINFUL BLISTER ON THE RIGHT BACKSIDE OF HER NECK. PT ADMITS THAT SHE TRIED TO "SELF-DIAGNOSE" AND THEREFORE DELAYED SEEKING MEDICAL ATTENTION. THE BLISTERS/SORES CONTINUED TO SPREAD THROUGH OUT NECK AND HEAD AREA IN THE DAYS FOLLOWING. PT WENT TO SEE PCP ON 4/19/21 (DR. INTERNAL AND FAMILY MEDICINE) WHERE SHE WAS DIAGNOSED WITH SHINGLES. PT WAS PRESCRIBED ACYCLOVIR AT THAT TIME. PT STATES SHE DOES NOT FEEL LIKE SHE HAS IMPROVED SINCE ONSET OF SYMPTOMS.
not feeling like her self; still tired and fatigued; no energy, all I could do was sleep all day; rapid heart rate; elevated blood pressure "140/100s; felt like my head was going to explode, felt like my heard was going to fall off.; no appetite was unable to eat or drink anything; cold sweats and was sweating profusely; cold sweats and was sweating profusely; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heart rate), BLOOD PRESSURE INCREASED (elevated blood pressure "140/100s), EXPLODING HEAD SYNDROME (felt like my head was going to explode, felt like my heard was going to fall off.), DECREASED APPETITE (no appetite was unable to eat or drink anything) and COLD SWEAT (cold sweats and was sweating profusely) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D NOS, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), FAMOTIDINE, OMEPRAZOLE, DUPILUMAB (DUPIXENT), AMLODIPINE BESILATE (NORVASC), GLYCERYL TRINITRATE (NITROGLYCERINE), MONTELUKAST SODIUM (SINGULAIR) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PALPITATIONS (rapid heart rate), BLOOD PRESSURE INCREASED (elevated blood pressure "140/100s), EXPLODING HEAD SYNDROME (felt like my head was going to explode, felt like my heard was going to fall off.), DECREASED APPETITE (no appetite was unable to eat or drink anything), COLD SWEAT (cold sweats and was sweating profusely), HYPERHIDROSIS (cold sweats and was sweating profusely) and FATIGUE (no energy, all I could do was sleep all day). On 20-Mar-2021, the patient experienced FEELING ABNORMAL (not feeling like her self) and FATIGUE (still tired and fatigued). On 21-Mar-2021, PALPITATIONS (rapid heart rate), EXPLODING HEAD SYNDROME (felt like my head was going to explode, felt like my heard was going to fall off.), DECREASED APPETITE (no appetite was unable to eat or drink anything), COLD SWEAT (cold sweats and was sweating profusely), HYPERHIDROSIS (cold sweats and was sweating profusely), FEELING ABNORMAL (not feeling like her self), FATIGUE (no energy, all I could do was sleep all day) and FATIGUE (still tired and fatigued) had resolved. On 24-Mar-2021, BLOOD PRESSURE INCREASED (elevated blood pressure "140/100s) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included albuterol inhaler.
Hosp from 1/13/10 to 2/19/10.  Per HPI - URI around 1/1/10 with no fever or chills.  Denies travel exposure.  On 1/11/10, noted bilateral finger tingling with right hand clumsiness and worsening bilateral hand numbness.  At admission, notes bilaeral foot numbness to mid-calf and worse R arm weakness.  Admit for 5 days of plasmapheresis.  Pt did not report any dyspnea, dysphagia, slurred speech, vision changes, diplolpia, bowel/bladder incontinence, back/neck pain, headache, recent trauma.  Per MR - MD conclude demyelinating dz like GBS vs cord compression.  GBS Surveillance neuro consult conclude not GBS or GBS variant since discrepency of reflexes.
had a slight reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had a slight reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a slight reaction). At the time of the report, IMMUNISATION REACTION (had a slight reaction) outcome was unknown.            Patient had no bad reaction with Pfizer booster dose. Patient had arm was just a tiny bit sore for a day or two. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
patient fainted immediately after for about 1 second, his head dropped but then he woke back up. right after the dose he began breathing quickly, so i instructed him to take his mask off and lay back if he needed. i grabbed him a water and took his blood pressure/hr. EMS was called, patient denied care. HIS BP WAS 104/73 AT 12:53 PM AND HIS hr WAS 72 BPM. I did notice some mild seizure like physical symptoms  as he woke up - arms and shoulders jerked a little for a few seconds. he said that the same, but worse, reaction happened after his first dose.
Headache, Myalgia, Arthralgia, NauseaVomiting,  injection site pain, chills Narrative:  Employee reports experiencing injection site pain/discomfort, chills, headaches, joint pain, body aches, fatigue, and nausea within a few hours of receiving vaccine. Reports took Aleve 500mg PO on 12/22/20 at 22:00, and another 500mg on 12/23/20 at 19:00. Employee reports all symptoms have gradually resolved with the exception of residual fatigue. Reports is able to work through fatigue though. Of note, employee does report previous adverse event with TDaP vaccine in 2020; reports experienced fever, chills, and very painful arm ("was difficult to move").
They are seborrheic keratosis but turned blue under the light; Sore arm; Black spots under both arms; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of SEBORRHOEIC KERATOSIS (They are seborrheic keratosis but turned blue under the light), PAIN IN EXTREMITY (Sore arm), RASH (Black spots under both arms) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M012M20A) for COVID-19 vaccination.     Concurrent medical conditions included LDL increased, Rosacea and Hyperchlorhydria. Concomitant products included OMEPRAZOLE for Hyperchlorhydria, ATORVASTATIN for LDL increased, METRONIDAZOLE (METROGEL) for Rosacea, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 12-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SEBORRHOEIC KERATOSIS (They are seborrheic keratosis but turned blue under the light), PAIN IN EXTREMITY (Sore arm), RASH (Black spots under both arms) and FATIGUE (fatigue). On 15-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved, FATIGUE (fatigue) was resolving. At the time of the report, SEBORRHOEIC KERATOSIS (They are seborrheic keratosis but turned blue under the light) and RASH (Black spots under both arms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: seborrheic keratosis (abnormal) Seborrheic keratosis.     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.   This case was linked to MOD-2021-102244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2021: New events were added. On 29-Apr-2021: Patient details, medical history, concomitant drugs, drug details and event outcomes were updated.
Very lethargic, muscle and joint aches , nausea. I had a dream I was beaten with a bat. That is how I was feeling at the time. (evening and night one) next morning same but started to feel a little better that afternoon/evening. the next day shaky legs but went on a little walk and threw up the following evening had very bad lower abdominal pain in lower right side and progressed to upper right thigh (like a charlie horse) kind of  on and off pain throughout the night. currently weak and tired but much better. (I hope thats it and its over)
Beginning 24 hours post injection, I had a moderate headache and painful  body aches. I also had a moderate level of fatigue. I went to bed early and woke up the next morning feeling less aches and pains. All symptoms subsided roughly 36-48 hours post injection.
Red, non-raised macular rash at sites distant from the smallpox vaccination site. Rash involves face, neck, upper back & chest, bilateral upper extremities. Not in distribution of creases and folds. Rash is itchy. No other sytemic symptoms. Rash appeared on day two post vaccination. No previous history of similar rash, no history of allergies. Patient itching treated with antihisamines. No other treatment provided. By day eight, rash is still present but much improved.   Discussed with CDC CIL team beginning on 2/26/03.
The rash is gone now but still can see the red from were it was; Looked at the arm and it had like a 6 inches rash; Just an allergy and that there was nothing to worry about; The area of the injection started to get itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Just an allergy and that there was nothing to worry about), VACCINATION SITE PRURITUS (The area of the injection started to get itchy), VACCINATION SITE RASH (Looked at the arm and it had like a 6 inches rash) and VACCINATION SITE ERYTHEMA (The rash is gone now but still can see the red from were it was) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2014) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (The area of the injection started to get itchy). On 22-Jan-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (Just an allergy and that there was nothing to worry about). On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Looked at the arm and it had like a 6 inches rash). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (The rash is gone now but still can see the red from were it was). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency and CETIRIZINE HCL at a dose of 10 milligram. At the time of the report, VACCINATION SITE HYPERSENSITIVITY (Just an allergy and that there was nothing to worry about), VACCINATION SITE PRURITUS (The area of the injection started to get itchy) and VACCINATION SITE ERYTHEMA (The rash is gone now but still can see the red from were it was) outcome was unknown and VACCINATION SITE RASH (Looked at the arm and it had like a 6 inches rash) had resolved.        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.   The concomitant medication included Hidrochloro Ciaside used for an unknown indication.  The patient consulted a physician on January 22nd who is not it's primary physician. and stated that it thought it was just an allergy and that there was nothing to worry about. The patient was concerned about receiving the second dose and said that the Dr stated that there was no problem receiving it. The patient stated that the rash is gone now but still can see the red from were it was.   This case was linked to MOD-2021-079735 (Patient Link).   Reporter did not allow further contact
Tested NAAT positive for COVID 11/17/21 after being fully vaccinated.
she had a panic attack and went to the hospital; Elevated heart rate; anxiety; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. (patient reported for self) A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02May2021 (at the age of 22-years-) as a dose 1, single for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported. She relayed that right after having the vaccine (on 02May2021) she experienced an elevated heart rate but that the nurses at the vaccine site checked her and she was fine. She stated that, she received the dose on a Sunday and then on that following Wednesday she had a panic attack and went to the hospital. She did not have anxiety before the vaccine. She stated that her mom thought that the anxiety may have been a side effect from the vaccine, but she was not sure. She mentioned that she drank coffee that morning as well. She would like to know if this was a known side effect after the vaccine and since she had an anxiety disorder now, would like to know if this was a reason that she shouldn't get the second dose. She did not receive the second dose as scheduled due to conflict in her schedule. She asked if she would still get the second dose of the vaccine or does she need to restart with the first dose again. She was advised to speak with HCP prior to receiving the second dose of the vaccine. Lab data included elevated heart rate on 02May2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.