chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TESTED POSITIVE FOR FLU; NOT FEELING SO WELL; "Not feeling so well"; A spontaneous report has been received from a health professional. The report concerns a child of unknown gender of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on 21-OCT-2022. The patient received 1 dose(s).     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 23-OCT-2022, the patient experienced not feeling so well (preferred term: Malaise). On 25-OCT-2022, the patient experienced tested positive for flu (preferred term: Influenza).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of not feeling so well and tested positive for flu was unknown.     The events were considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Pt complained of disorientation and also of right upper are redness, soreness and swelling. The next day pt experienced lethargy for 6 hours.
This spontaneous report as received from a pharmacist refers to a 53 year old patient who underwent an unspecified chemotherapy for unspecified condition; this was a chemotherapeutic agent that the patient received every 3 weeks. The patient received ZOSTAVAX (dose, route, lot # and expiration date were not reported) within the last 10 days (14-DEC-2015 to 23-DEC-2015). So, chemotherapy and vaccination occurred in same time frame. The pharmacist stated patient "likely considered immunosuppressed" which was contraindication to receiving ZOSTAVAX. The pharmacist also reported, that the patient was being treated by an unspecified physician who had completed unspecified lab work at an unspecified time either prior to or after ZOSTAVAX vaccination (pharmacist was unable to confirm), that revealed elevation in unidentified "rheumatologic values" (values and units not reported) (laboratory test abnormal). The treatment had not bee initiated based on recent ZOSTAVAX vaccination and ongoing chemotherapy regimen. The outcome of laboratory test abnormal was unknown. The relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information has been requested.
Fever, chills, body aches, headache, joint pain, fatigue for 8 hours Fatigue for 18 hours Red, splotchy skin appeared after 36 hours
Indentation or atrophy, redness and pain 30 days after vaccine administered. She was given Ibuprofen and CEPHALEXA for 10 days.
On  4/7/21 patient was unable to go to work due to fatigue.  She was sent home from a free-standing ER who reported she most likely had a viral illness.  She passed out getting into the bathtub and presented to Hospital.  At this hospital her chief complaints were excessive fatigue, myalgia, fever, chills.  She was diagnosed with TTP with portal venous thrombosis.  She was refractory to high dose steroids, plasmapheresis, and rituximab x2.  She is now set to begin treatment with caplacizumab and is currently on day 12 of hospitalization.
I HAD A POSITIVE TEST RESULT FOR COVID 19 ON JANUARY 4 2022. I TOOK THE TESTS BECAUSE I HAD BEEN EXPOSED TO ANOTHER PERSON WHO HAD TESTED POSITIVE 3 DAYS PRIOR. HE HAD VERY MILD SYMPTOMS AND HIS WIFE TESTED NEGATIVE. MY PARTNER ALSO TESTED NEGATIVE. AT THE TIME OF THE TEST I WAS MOSTLY ASYMPTOMATIC. LATER I HAD RUNNY NOSE, A PRODUCTIVE COUGH, SOME NASAL AND CHEST CONGESTION, AND HEADACHED. I QUARANTINED MYSELF FROM 1/3 UNTIL THE PRESENT. I INTEND TO CONTINUE MY QUARANTINE UNTIL 1/13 SINCE MOST SYMPTOMS HAVE SUBSIDED AND NEVER WERE TOO SEVERE. I PLAN A TEST ON 1/13.
A report was received from a health care professional on 11/20/03 concerning a male vaccinee in his 50's who experienced a redness at the site of injection 2 days after inadvertently receiving Fluvirin via a needleless injector on 10/20/03. On 10/22/03 the vaccinee experienced redness at the site of injection after inadvertently receiving Fluvirin via a needleless injector. The redness lasted a few days and had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
My menstrual cycle never came in august. I received my swings dose in September and started the very next day but with a vengeance. I have very regular menstrual cycles and even thought I could have been pregnant, took 2 pregnancy tests to confirm I wasn?t, even tho I had a tubal ligation a few years ago. After I received my second dose and my period came two week earlier than normal, I was in an immense amount of pain from really bad cramping and experienced huge blood clots. It was very strange.
Moderna Covid 19- Vaccine EUA   Right arm redness, swelling, induration and pruritus
NEUROPATHY 8/24/2021 MULTIPLE MYELOMA  NEUROPATHY 8/24/2021 ANEMIA
she had a disc that was ruptured; she had a bruise; Bang on the elbow and knee; elbow was losing strength; accident happened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: EWA53) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "heart disorder" (unspecified if ongoing); "Prosthetic knee" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder; NYQUIL taken for hypertension; TYLENOL taken for joint prosthesis user, arthritis. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot no.EN6208), administration date: 11Mar2021, for Covid-19 immunization; Pneumonia shots, for Immunisation. The following information was reported: ACCIDENT (medically significant) with onset 16Jun2021, outcome "unknown", described as "accident happened"; INTERVERTEBRAL DISC PROTRUSION (medically significant), outcome "unknown", described as "she had a disc that was ruptured"; CONTUSION (medically significant), outcome "unknown", described as "she had a bruise"; JOINT INJURY (medically significant), outcome "unknown", described as "Bang on the elbow and knee"; MUSCULAR WEAKNESS (medically significant), outcome "unknown", described as "elbow was losing strength". Therapeutic measures were taken as a result of accident, intervertebral disc protrusion, contusion, joint injury, muscular weakness. Clinical Course: She did not take flu shots, she had only taken pneumonia shots, she did not get sick, very seldom she got sick, if she felt anything like a scratchy throat or runny nose she usually took Blood pressure cold medicine Coricidin, she would take a couple of those and feel fine. No details were provided on patient's other conditions and investigations. Patient's weight was 160lbs-175lbs. She had back surgery, in September they cut in the stomach, because she had this accident with 2 guys, the guy ran in the back, spun her around, she thought she just walked away but she had a bruise, bang on the elbow and knee. Her elbow was losing strength, it was the nerve, she had a disc that was ruptured, it was Spinal pressure, the accident happened 16Jun2021, but the Surgery was 24Sep2022 that was the first surgery, the second surgery on 26Sep2022, they couldn't do both in one day because of long hours, they had to go in back and put the trinkets in the back with 2 screws. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109929 same patient and product, different dose and events.;
patient stayed here for 15 minutes and did well. She went back to her job and developed flushed feeling, hives on neck and tingling on tongue.  She improved with no treatment.
Patient went to the doctor today and was diagnosed with capsulitis.  She was given a steriod regimen.
Tender posterior cervical lymphadenopathy, rash day 15-18 faint, left wrist discomfort, mild soft tissue swelling.
I had a severe joint pain and swallow in my joints (October 1st) and severe fatigue syndrome, going and off since the time of the vaccine about one month ago when I develop a new problem, in August similar issues of my 2nd dose started,  with severe inflammation, ulcer in the entire goat and mouth, that makes me severe diarrhea and weight loss and abdominal pain and the doctor did an endoscopy and biopsy in the small and large valve, and started me on medication. In the last month I had severe joint pain again.
the night of vaccine she had flu like symptoms without fever.  she had shingles like rash on left side that moved to right side on 11/12/20. she has 7 spots on trunk and legs
High fever,  body aches, chills, and fatigue all at once. Took two Advil?s which decreased fever and chills. Still have fever, body aches, and fatigue.
Moderna COVID-19 Vaccine EUA Sore arm at injection site; headache, feeling of malaise, no energy beginning approximately at 10 p.m. five + hours after injection. Headache and symptoms lasted all night and continued for the next day, about 36 hours in total. Soreness in arm lasted through the weekend but was better each day.
Swollen right arm at injection site. Site also red and sore.  Very painful and itching.  Took Advil, applied ice and heat. Swollen site approx 3" x 3". Temp the second day and night of 99.5, sore and achey all over. Large knot began shrinking approx. 5 days later.  Still have what feels like two small marbles under the skin 9 days later.
broke into a sweat; tenderness; little fatigued; very low fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very low fever), HYPERHIDROSIS (broke into a sweat), TENDERNESS (tenderness) and FATIGUE (little fatigued) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination.     No Medical History Reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), SOTALOL, LOSARTAN and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PYREXIA (very low fever), TENDERNESS (tenderness) and FATIGUE (little fatigued). On 17-Apr-2021, the patient experienced HYPERHIDROSIS (broke into a sweat). At the time of the report, PYREXIA (very low fever), HYPERHIDROSIS (broke into a sweat), TENDERNESS (tenderness) and FATIGUE (little fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   Treatment information not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-142492 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142492:crosslinked; wife case
On Feb 12, nine days after the vaccination, the site of the shot began to itch.  On the morning of Feb 13, the site was red and felt warm to the touch.
pt recvd vax; to ofc w/ inject site rxn to erythema,tenderness & swelling;
Pins and needles in hands and feet with shooting pain in digits, vertigo that prevents work and chores,etc, dizziness and weakness that prevents prolonged standing
Red swollen toes on my left foot with small clear bumps that severely itched. Put cortisone on the toes and covered loosely with a bandage. Was gone by next day.
Given Gardasil #1 5-14-07 - 1 week later - developed tingling, numbness (L); 10-29-07 - Gardasil #2 - 1 week later - to ED - c/o LLE pain, tingling; MRI done; admitted to hospital 11-3 - 11-08.  4/22/08 Reviewed hospital medical records for 11/4-11/8/2007. FINAL DX: Transverse myelitis Records reveal patient experienced stomach upset right leg numbness/tingling paresthesia, weakness & unsteady gait progressing over a 10-day period to include abdomen/chest only on right side.  Had a similar episode in left arm 3 wks prior that resolved.  Neuro consult done.  Tx w/IV steroids & sensory symptoms resolved & weakness improved.  D/C home on tapering oral steroids to f/u w/neuro.
Patient reported tingling of the tongue 10 minutes after 2nd dose of Moderna vaccination. No swelling/ redness/ hives noted. 25mg Benadryl PO administered. Vital signs stable throughout observation. Reports hx. of anaphylaxis from iodine. 11:56a.m. Tingling in tongue improved, no further symptoms. 12:00pm Discharged from clinic with instructions to go to ED / call 911 if symptoms persist or worsen.
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as  health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events.  Information on the batch/lot number has been requested.
1 1/2 hrs p/vax pt started to break out in hives; notified clinic was referred to pvt MD; MD gave DPH;
This medically confirmed spontaneous report (initial receipt: 21-Nov-2011) concerns a 58-year old female patient, who had a medical history of sleeplessness and 'nerves'. On 18-Nov-2011 the patient received 0.5 mL of AFLURIA (batch number: N56506A) intramuscularly in LD (left deltoid). On 20-Nov-2011, the patient developed a painful fever blister on her lip, a sore throat and a 3 inch rash on her leg and a 5 inch rash on her stomach. She never had a fever blister before. The patient visited a doctor and was diagnosed with strep throat and shingles. She did not receive any treatment for the event. The event outcome was recovered. The reporter considered 'strep throat' and 'shingles' to be unrelated to AFLURIA. Follow up (16-Dec-2011): suspect drug administration site, additional AE terms, event summary description, event outcome, reporter's causality assessment, company seriousness assessment, upgraded to serious.
Chest pain, localized skin reaction, arthralgia, generalized malaise, fatigue and muscle ache.
It started with body aches on Wednesday and I had a low fever up until Monday. On Monday I had a high fever, 104, I took Tylenol and it went down but never under 100. That lasted for 3 days and after that I had low fevers for about 4 more days. My temperature was not normal it was up in the 98-99 range up until almost 3 weeks later. I did a video appointment with my doctor's office and I went to ER once and urgent care once. All they did told me to take Advil and Tylenol and I had blood work done that came back with elevated numbers but nothing that would explain this. They said it was a really bad viral infection.  I have an appointment with a specialist to try to figure out what was wrong with me. To see if it is an autoimmune disease.  I do not have any more fevers or body aches but because of the severity of the fevers and how long it lasted they want to check for autoimmune diseases.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 58-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No acute illness at the time of vaccination.  The patient's past medical history included COVID-19 (felt really bad, achy, had a headache and dry cough. Tested positive in last days of Jun-2022) from June 2022 to 2022 and Streptococcal infection in 2022. Concurrent medical conditions included Allergy to antibiotic (Macrolide antibiotic) and Blood pressure abnormal. Concomitant products included LOSARTAN POTASSIUM for Blood pressure abnormal.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Tested positive in last days of Jun-2022. In 2022, Streptococcus test: (Positive) Positive.         It was reported that the patient tested positive for COVID-19 and Streptococcus after receiving some of the Moderna COVID-19 vaccines.  It was reported that patient received 5 doses of the Moderna COVID-19 Vaccine, the primary series 2 and 3 boosters.  The patient felt really bad, achy, had a headache and dry cough and then tested positive for COVID-19 and Streptococcus. The patient was diagnosed with COVID-19 on the last days of Jun-2022.The major symptoms lasted a few days, then the patient just had a dry cough.  Sore arm had not caused the patient to seek medical care and patient had not experienced a similar event in the past. The patient had not experienced a similar event in the past. Patient experienced sore arm in sep-2022 and resolved in sep-2022. Patient took antivirals and antibiotics as treatment.   This case was linked to MOD-2022-643462 (Patient Link).
Two days after receiving first dose, my face started itching. Over the course of the next few days my face became red, patchy, flaky and my neck had a rash as well. Went to clinic and prescribed oral steroids. Face cleared up but neck persisted. Went back to clinic 1 day after receiving second vax and was prescribed topical steroid cream for my neck. Neck cleared up and then a week later face started flaring up again. Went to clinic and suggested hydrocortisone for face. That got better and been about a week and a half but still experiencing mild flare ups of face, neck, and now hands. Cannot think of anything else I could be reacting too. Also been taking an oral anti-histamine every day  since day three post first vax.
Pt received an adult dose of HAVRIX Hep A vaccine 1.0ml. No reaction occurred.
Myalgia & Diarrhea Narrative:  Per employee, 14 hours after vaccination, felt abdominal cramps followed by watery diarrhea and sore left arm (vaccine site). No hx of changes in food prep nor diet 1/1/2021. Denied fever, some sniffles (chronic) diarrhea improving bowel movement mid morning following day
Patient had gotten COVID-19 vaccine (Pfizer) and he had finished his 15 minutes waiting time. We was leaving when his wife and his mother mentioned he had swollen eyes. Pt said he was feeling well and that his eyes were fine. However, family member insisted he had an allergic reaction to the vaccine and he mentioned he started to feel lightheaded and nervous afterwards. His BP was 107/81 mmHg and pulse 100 bpm and he mentioned he wanted to take something for allergies, so patient was given 50 mg Benadryl after confirming his weight (80 kg). After 15 minutes waiting, patient mentioned he was feeling fine, and he wanted to leave. BP was taken again and it was 125/76 mmHg and pulse was 89 bpm. Pt refused calling 911 because he was feeling ok and he did not feel his eyes swollen.
Shortly after 1200 Nurse was returning from where she was pulled to assist a patient. This was during our lunch period so we only had two nurses to assist with patients and a long line developed so she stayed to draw up medication, so the other nurses could continue to take patients. She went into the small cooler and pulled Pfizer monovalent, which had been placed in separately labeled "Monovalent" bag in its original packaging with the regional label. All nurses had been advised of this and told to check the packaging as well as the vial for the bivalent label. The nurse made a mistake and pulled two vials of the monovalent vaccine and drew them up but noted the different lot number with the other nurses. The administering nurse proceeded to take and vaccinate 4 patients with this vaccine. The mistake was noticed when a first dose patient came in for Pfizer and she went to pull a monovalent vaccine, she noticed that the lot number was the same as what she was told was the bivalent vaccine. They immediately reported to me the manager and I immediately pulled the vaccines from the floor, collected the patient?s information that were given the incorrect dose. I reported this to my director and the next steps were decided upon. Patient was notified.
CHILLS,  BODY ACHES,HEADACHE, SWEATS, LIGHT FEVER
Patient was given booster dose and was not yet eligible. Second dose was recorded as 9/27/2021
side effects to the Moderna vaccines; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effects to the Moderna vaccines) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy (Patient's reaction was violent nausea and vomiting, fine the next day (09-Mar-2021) and had resolved) from 08-Mar-2021 to March 2021. Concurrent medical conditions included Allergy to antibiotic, Alpha-1 antitrypsin deficiency (No recent changes in the status) since 2015 and Diabetes (2 years ago. No recent changes in the status.).    On 20-Mar-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 IMMUNISATION REACTION (side effects to the Moderna vaccines). At the time of the report, IMMUNISATION REACTION (side effects to the Moderna vaccines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information provided. Patient had never tested positive or diagnosed with COVID-19  No other vaccine was taken by the patient within one month prior to Moderna COVID-19 Vaccine.  On 17-APR-2021, the patient received second dose of Moderna COVID-19 Vaccine. No treatment medication information provided.   This case was linked to MOD-2022-597763, MOD-2022-597762 (Patient Link).